Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes TEDDY data through the TEDDY 2022 funding period and additional analysis datasets for M38b, M70, M140, and M171. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

A new study, Multidisciplinary Approach to the Study of Pelvic Pain Twin Study (MAPP Twin), has been posted to the NIDDK Central Repository. Data and specimens from this study are now available for request. The Pelvic Pain Twin Study was a small, pilot study conducted at one MAPP Network Discovery site during MAPP Phase I using a unique sample of female, community-based twins from the University of Washington Twin Registry. This effort represented a co-twin control study, with pairs that were discordant for IC/PBS and was designed to identify IC/PBS phenotypes, characterize pathological and physiological associations with IC/PBS, and describe the relationship between IC/PBS and related chronic overlapping pain conditions (COPCs).

Data have been updated for Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis Liver Disease (CFLD PUSH). This update includes final study datasets. If you have already been approved to receive the CFLD PUSH data package, please contact us through your request to download the updated data package. The Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis Liver Disease (CFLD PUSH) study was a prospective longitudinal study that aimed to determine the utility of abdominal ultrasound to predict the development of cirrhosis in participants with cystic fibrosis as indicated by a nodular liver on ultrasound.

Data have been updated for Antithymocyte Globulin (ATG) and Pegylated Granulocyte Colony Stimulating Factor (GCSF) in New Onset Type 1 Diabetes (TN19). This update includes additional flow analysis datasets. If you have already been approved to receive the TN19 data package, please contact us through your request to download the updated data package. The TN19 study was a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which participants either received active Anti-Thymocyte Globulin (ATG) and Granulocyte Colony Stimulating Factor (GCSF), received ATG alone, or received a placebo alone within 100 days from diagnosis of T1D. TrialNet researchers assessed whether ATG used alone or in combination with GCSF helped participants continue to make some of their own insulin.

A new study, Longitudinal Assessment of Transient Elastography in Cystic Fibrosis (ELASTIC-CF), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The ELASTIC-CF study assessed if combining FibroScan® measurement of liver stiffness transient elastography with ultrasound would improve the prediction of the development of a nodular liver on ultrasound and development of portal hypertension over time in children and young adults with CF. Study visits occurred at baseline and for at least two annual follow-up visits.

A new study, Validation of Bladder Health Instrument for Evaluation in Women (VIEW), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The VIEW study prospectively collected data to test and validate bladder health instrument (BHI) items for inclusion in a final bladder health scale (BHS) that assessed the full range of bladder health of women. The study collected data from the general population using mailed surveys, from the clinical population using surveys and in-person evaluations, and from postpartum women.

A new study, Biliary Atresia Study in Infants and Children (BASIC), has been posted to the NIDDK Central Repository. Analysis data from this study are now available for request as well as three analysis datasets using combined data from the PROBE and BASIC studies. The Biliary Atresia Study in Infants and Children (BASIC) is a prospective, observational study that was established by ChiLDReN to collect pertinent clinical information and biospecimens to aid in the understanding of the disorder. Specific aims of the study include identifying the gene(s) implicated in the etiology of biliary atresia, identifying the polymorphisms that may influence disease progression, and characterizing the natural history of the older, non-transplanted patients with biliary atresia.

A new study, Rare and Atypical DIAbetes NeTwork (RADIANT), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The Rare and Atypical DIAbetes NeTwork (RADIANT) is a multicenter prospective cohort study that is dedicated to characterizing (discovering and defining) rare and atypical forms of diabetes. Individuals will be screened for evaluation of suspected atypical diabetes of unknown origin. Among the pool of evaluated individuals, those found to have a known form of diabetes will be excluded from further study. The remaining participants will be prioritized for genetic/genomic analysis and further testing.

Data have been updated for the Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC) study. This study is part of the Childhood Liver Disease Research Network (ChiLDReN). An additional analysis dataset is now available for request. If you have already been approved to receive the LOGIC data package, please contact us through your request to download the updated data package. The primary objectives of the LOGIC study include determining the frequency of poor growth and decreased bone mineral density and its predictors; identifying modifier genes that influence the incidence, severity, and progression of liver disease among affected individuals; and developing a repository of biospecimens to be used in ancillary studies of predictor biomarkers.

Data have been updated for A Prospective Database of Infants With Cholestasis (PROBE). This update includes an analysis dataset from PROBE. Additionally, this update includes three analysis datasets using combined data from the PROBE, BASIC, and START studies. If you have already been approved to receive the PROBE data package, please contact us through your request to download the updated data package. PROBE is a multi-center project to establish a prospective database of clinical information and a repository of blood and tissue samples from children with diagnoses of neonatal liver diseases, such as biliary atresia and neonatal hepatitis in order to perform research in these liver problems.

Data have been updated for Careful Urinary Tract Infection Evaluation (CUTIE). This update includes an additional renal scan dataset. If you have already been approved to receive the CUTIE data package, please contact us through your request to download the updated data package. The CUTIE study was an observational study designed to determine why some children develop kidney scars after urinary tract infections (UTIs). The study was aimed at understanding which children were at the greatest risk of developing renal scarring following a UTI, so physicians can provide targeted therapies and appropriate interventions.

Data have been updated for The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C). This update includes Biopsy Adverse Event data. If you have already been approved to receive the HALT-C data package, please contact us through your request to download the updated data package. The Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial (HALT-C) was a randomized clinical trial of long-term use of peginterferon alfa-2a in participants with chronic hepatitis C. The study investigated whether long-term antiviral therapy could prevent progressive liver disease—including cirrhosis, liver failure, hepatocellular carcinoma, and death—in chronic hepatitis C participants.

Data have been updated for Diabetes Prevention Program (DPP). This update includes PFAS (per- and polyfluoroalkyl substances) Secondary data. If you have already been approved to receive the DPP data package, please contact us through your request to download the updated data package. The Diabetes Prevention Program (DPP) is a clinical trial that investigated whether modest weight loss through dietary changes and increased physical activity or treatment with the oral diabetes drug metformin (Glucophage) could prevent or delay the onset of type 2 diabetes in high risk individuals with prediabetes.

Data have been updated for Diabetes Prevention Program Outcomes Study (DPPOS). This update includes Phase 3 data and PFAS (per- and polyfluoroalkyl substances) Secondary data. If you have already been approved to receive the DPPOS data package, please contact us through your request to download the updated data package. The Diabetes Prevention Program Outcomes Study (DPPOS) is the long-term follow-up of the original DPP (Diabetes Prevention Program) study. The DPPOS sought to evaluate the effects of the interventions on the further development of diabetes and diabetes complications, including retinopathy, microangiopathy, and cardiovascular disease.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M199, M208, M233, and M239. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

Data have been updated for Anti-CD3 Mab (Teplizumab) for Prevention of Diabetes in Relatives At-Risk for Type 1 Diabetes Mellitus (TN10) study. This update includes additional secondary outcomes analysis datasets. If you have already been approved to receive the TN10 data package, please contact us through your request to download the updated data package. TN10 was a phase 2 prevention trial of TrialNet, studying the effect of teplizumab on insulin production in the relatives of type 1 diabetics who were at high risk of developing the disease. Participants were randomly assigned to either the active or placebo group of the study and monitored and tested over time until diagnosed with diabetes.

Data have been updated for A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy in Infants with Biliary Atresia (START) study. This update includes an additional vitamin deficiency analysis dataset, and two analysis datasets using combined data from the Prospective Database of Infants with Cholestasis (PROBE) and START studies. If you have already been approved to receive the START data package, please contact us through your request to download the updated data package. The START study participants were recruited from the PROBE study and randomized into either the corticosteroid or placebo group within 72 hours after the portoenterostomy procedure. Participants were given their assigned treatments daily over the course of 13 weeks. After the treatment period, participants underwent follow-up testing and assessments until age 24 months.

Data have been updated for FibroScan in Pediatric Cholestatic Liver Disease (FORCE) study. This update includes an additional biomarkers analysis dataset. If you have already been approved to receive the FORCE data package, please contact us through your request to download the updated data package. The FibroScan in Pediatric Cholestatic Liver Disease (FORCE) study, a natural history study within ChiLDReN, was a cross-sectional and longitudinal assessment of the utility of liver stiffness measurement (LSM) in children with chronic cholestatic liver disease.

A new study, Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects with Alagille Syndrome (IMAGINE-II), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The IMAGINE-II study was a multicenter, extension study of LUM001 in children diagnosed with Alagille syndrome (ALGS) who had completed participation in a core LUM001 treatment protocol (ITCH study). Efficacy was assessed by evaluating the effect of LUM001 on the biochemical markers and pruritus associated with ALGS.

A new study, A Phase I/IIa Trial of Intravenous Immunoglobulin (IVIG) Therapy Following Portoenterostomy in Infants with Biliary Atresia (PRIME), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The PRIME study was a multicenter prospective phase I/IIa open label trial, aimed at assessing the feasibility, tolerability, and safety of intravenous immunoglobulin (IVIG) therapy following hepatic portoenterostomy (HPE) in infants with biliary atresia (BA).

A new study, Nonalcoholic Fatty Liver Disease Pediatric Database 2 (NAFLD Pediatric Database 2), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) was initiated in 2002 to conduct multicenter, collaborative studies on the etiology, contributing factors, natural history, complications, and treatment of NASH. The Nonalcoholic Fatty Liver Disease Pediatric Database 2 (NAFLD Pediatric Database 2) continued the longitudinal follow-up of participants enrolled in earlier NASH CRN studies and recruited new participants with recent liver biopsies.

Data have been updated for the Adolescent Bariatrics: Assessing Health Benefits & Risks (Teen-LABS) study. This update includes data through the end of the study and additional analysis datasets. If you have already been approved to receive the Teen-LABS, please contact us through your request to download the updated data package. Teen-LABS conducted coordinated clinical, epidemiological, and behavioral research focused on adolescent bariatric surgery. The study developed common clinical protocols and a bariatric surgery database for the purpose of collecting information from participating clinical centers that performed bariatric surgery on teenagers.

A new study, Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B (HBRN Immunology Cohort), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B (HBRN Immunology Cohort) study aimed to assess whether the balance between immune regulatory and effector responses in HBV-infected individuals defines the level of viremia, liver inflammation, and treatment outcomes.

A new study, Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B (HBRN Immunology Treatment), has been posted to the NIDDK Central Repository. Data from this study are now available for request. Immune Regulation and Costimulation in Natural History and Therapeutic Outcome of Chronic Hepatitis B (HBRN Immunology Treatment) study sought to examine the effects of antiviral therapy in host immune phenotype and to investigate if antiviral immune responses before, during, and after therapy can predict long term therapeutic response.

A new study, Nonalcoholic Fatty Liver Disease Adult Database 2 (NAFLD Adult Database 2), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) was initiated in 2002 to conduct multicenter, collaborative studies on the etiology, contributing factors, natural history, complications, and treatment of NASH. The Nonalcoholic Fatty Liver Disease Adult Database 2 (NAFLD Adult Database 2) continued the longitudinal follow-up of participants enrolled in earlier NASH CRN studies and recruited new participants with recent liver biopsies.

A new study, Combination Therapy of Peginterferon Alfa-2a and Tenofovir versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B (HBRN Immune Active), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The Combination Therapy of Peginterferon Alfa-2a and Tenofovir versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B (HBRN Immune Active) study sought to compare the long-term efficacy of combination therapy with peginterferon plus tenofovir versus tenofovir monotherapy in the treatment of chronic hepatitis B.

A new study, Clinical Trial of Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic HBV Infection (HBRN Immune Tolerant P), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The HBRN Pediatric Immune Tolerant Trial (HBRN Immune Tolerant P) sought to determine the safety and efficacy of treatment using a combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old with immunotolerant chronic hepatitis B.

A new study, Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults with Chronic Hepatitis B (HBRN Immune Tolerant A), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The HBRN Adult Immune Tolerant Trial (HBRN Immune Tolerant A) was designed to determine the efficacy of treatment with 8 weeks of entecavir followed by 40 weeks of both entecavir and peginterferon in the treatment of chronic hepatitis B in hepatitis B “e” antigen (HBeAg) positive adults who were in the immune tolerant phase.

Data have been updated for the Hepatitis B Research Network Pediatric Cohort Study (HBRN Cohort P). This update includes final study datasets, analysis datasets, and additional ancillary datasets. If you have already been approved to receive the HBRN data package, please contact us through your request to download the updated data package. The HBRN Pediatric Cohort Study (HBRN Cohort P) was designed to describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression.

Data have been updated for the Hepatitis B Research Network Adult Cohort Study (HBRN Cohort A). This update includes final study datasets, analysis datasets, and additional ancillary datasets. If you have already been approved to receive the HBRN data package, please contact us through your request to download the updated data package. The HBRN Adult Cohort Study (HBRN Cohort A) was designed to describe participants with hepatitis B virus (HBV) infection and identify predictors of disease activation and progression. The relationship of HBV genotype to clinical, biochemical, and histological characteristics and to pregnancy was also explored.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes TEDDY data through 2021. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

Data have been updated for the Chronic Renal Insufficiency Cohort Study (CRIC). This update includes updated datasets. If you have already been approved to receive the CRIC data package, please contact us through your request to download the updated data package. The Chronic Renal Insufficiency Cohort (CRIC) Study is an observational study that examined risk factors for progression of chronic renal insufficiency (CRI) and cardiovascular disease (CVD) among CRI patients. The study enrolled adults aged 21 to 74 years with a broad spectrum of renal disease severity, half of whom were diagnosed with diabetes mellitus. Subjects underwent extensive clinical evaluation at baseline and at annual clinic visits and via telephone at 6 month intervals.

A new study, Losartan for the Treatment of Pediatric Nonalcoholic Fatty Liver Disease (STOP-NAFLD), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The STOP-NAFLD trial was a multicenter, double-masked, placebo-controlled, randomized phase 2 trial designed by the Nonalcoholic Steatohepatitis Clinical Research Network (NASH) to determine whether treatment with losartan improves measures of NAFLD in children.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M78, M144, M210, and updated TEDDY data through 2020. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

Data have been updated for the Acute Liver Failure Study Group: Adult Acute Liver Failure Study (AALF). Additional study datasets are now available for request. If you have already been approved to receive the AALF data package, please contact us through your request to download the updated data package. ALFSG conducted a Multi-Center Trial to Study Adult Acute Liver Failure (AALF) with acute liver failure and acute liver injury participants and those less severe that had coagulopathy but not the threshold of encephalopathy, a pilot study with a subset of AALF participants using rotational thromboelastography as a dynamic measure of coagulation, and a clinical trial with a subset of AALF participants using 13C labeled methacetin breath testing to determine outcomes in acute liver failure patients being considered for transplantation.

A new study, The MAPP II Study of Urologic Chronic Pelvic Pain Syndrome: The Trans-MAPP Symptom Patterns Study (MAPP II), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The second phase (MAPP II) of the NIDDK Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network was designed to conduct a prospective, observational study of men and women with urologic chronic pelvic pain syndrome (UCPPS). A central goal of MAPP II, like MAPP I, was to create a new knowledge base for informing future, targeted UCPPS clinical trials and ultimately to provide insights that will improve the clinical management of patients.

Data have been updated for the Multidisciplinary Approach to the Study of Pelvic Pain (MAPP I). This update includes updated datasets and new derived variables for the MAPP I study. If you have already been approved to receive the MAPP I data package, please contact us through your request to download the updated data package. The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network was established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men. Participants with some form or symptoms of IC or CP were asked to join the Trans-MAPP Epidemiology and Phenotyping (EP) Study. Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome (CFS)) were recruited for the Trans-MAPP Control Study. These participants were a reference/control group for the Trans-MAPP EP Study.

Data have been updated for the Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study (LURN). Clinical, Qualitative, and Cognitive interview transcripts are now available for request. If you have already been approved to receive the LURN data package, please contact us through your request to download the updated data package. The Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study (LURN) was established to gain a better understanding of lower urinary tract symptoms in an effort to improve the lives of those with lower urinary tract dysfunction. LURN participants were enrolled at multiple sites within the United States. Participants were assigned to one of four subgroups, based on their symptoms, the outcomes of clinical assessments, and other characteristics. Biological samples were collected from study participants and patients were required to complete certain assessments and examinations at standard time-points during the study period.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M107 and M221. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

A new study, Biomarker Collection and Analysis in the Prevention of Serious Adverse Events Following Angiography (PRESERVE) Trial Cohort, has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The Biomarker Collection and Analysis sub-study collected, banked, and analyzed blood and urine of participants from the VA-funded PRESERVE trial. Blood and urine proteins and other markers may predict the development of contrast-induced acute kidney injury and diagnose the very early stages of this condition following angiography.

A new study, Lifestyle Interventions for Expectant Moms (LIFE-Moms), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The LIFE-Moms consortium was a network of seven clinical centers and a data coordinating center to identify effective behavioral and lifestyle interventions that improve weight, glycemic control, and outcomes in obese and overweight pregnant women and their children.

A new study, Observational Study of Hepatitis B Virus (HBV) in Patients Co-Infected with Human Immunodeficiency Virus (HIV) (HBRN HIV Co-Infection), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The Hepatitis B Research Network (HBRN) was the first major effort to elucidate the natural history and treatment outcomes of persons with chronic HBV in the U.S. This HBRN ancillary study provided a unique opportunity to fill major gaps in HBV-HIV knowledge and to compare HBV-HIV infected persons to those with HBV monoinfection participating in the HBRN.

A new study, Nephrotic Syndrome Study Network (NEPTUNE), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The NEPTUNE cohort study is a prospective, observational study that enrolls children and adults with FSGS, MCD, and MN. Participants have a proteinuria ≥ 500 mg/day, estimated from a 24-hour or protein to creatinine ratio urine collection. Participants with sub-nephrotic proteinuria are also included to capture the broad spectrum of clinical presentation.

A new study, Efficacy and Safety of the Intestinal Bile Acid Transport (IBAT) Inhibitor LUM001 in the Treatment of Pruritus in Alagille Syndrome Patients (ITCH), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The ITCH study was a randomized, double-blind, placebo-controlled, parallel group, multi-center study in children with Alagille syndrome (ALGS). The study was designed to investigate the effects of LUM001 (Maralixibat), compared to placebo, on pruritus, serum bile acids, liver enzymes, and other biochemical markers associated with cholestatic liver disease, following daily dosing over a 13-week period.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M55, M115, and additional files for the M109 package. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

A new study, Diabetes Autoimmunity Study in the Young (DAISY), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The DAISY study follows children determined to be at an increased risk for development of type 1 diabetes (T1D), either due to known genetic markers or due to family history of T1D, and monitors them on an annual basis for development of T1D-related autoimmunity.

A new study, Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus (TN20 IEOI), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The TrialNet (TN20) study was a two-arm, multi-center, randomized, open-labeled clinical trial designed to assess the effects of varying doses and schedules of oral insulin on immunological and metabolic markers in relatives at risk for type 1 diabetes (T1D).

Data have been updated for the Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC) study. This study is part of the Childhood Liver Disease Research Network (ChiLDReN). Analysis datasets from three publications are now available for request. If you have already been approved to receive the LOGIC data package, please contact us through your request to download the updated data package. The primary objectives of the LOGIC study include determining the frequency of poor growth and decreased bone mineral density and its predictors; identifying modifier genes that influence the incidence, severity, and progression of liver disease among affected individuals; and developing a repository of biospecimens to be used in ancillary studies of predictor biomarkers.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M93, M190, and M202. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

Data have been updated for the Prospective Database of Infants with Cholestasis (PROBE). This update includes analysis datasets from four publications including combined data from the Biliary Atresia Study in Infants and Children (BASIC) and Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC) studies. If you have already been approved to receive the PROBE data package, please contact us through your request to download the updated data package. PROBE is a multi-center project to establish a prospective database of clinical information and a repository of blood and tissue samples from children with diagnoses of neonatal liver diseases, such as biliary atresia and neonatal hepatitis, in order to perform research in these liver problems

A new study, Predicting Response to Standardized Pediatric Colitis Therapy (PROTECT), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. This multicenter open-label study was designed to evaluate the safety and efficacy of standardized initial therapy using either mesalamine or corticosteroids then mesalamine for the treatment of children and adolescents newly diagnosed with ulcerative colitis.

Data have been updated for the ATG-GCSF in New Onset Type 1 Diabetes Study (TN19 ATG-GCSF). This update includes final study datasets and secondary ImmunoChip results data. If you have already been approved to receive the TN19 data package, please contact us through your request to download the updated data package. The TrialNet 19 (TN19) study was a three-arm, 1:1:1 randomized, placebo controlled, double- blinded trial in which participants either received active Anti-Thymocyte Globulin (ATG) and Granulocyte Colony Stimulating Factor (GCSF), received ATG alone, or received a placebo alone within 100 days from diagnosis of type 1 diabetes. TrialNet researchers assessed whether ATG used alone or in combination with GCSF helped participants continue to make some of their own insulin.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M72 and M179. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

Data have been updated for the Multidisciplinary Approach to the Study of Pelvic Pain (MAPP1). This update includes full study data for the MAPP1 study. If you have already been approved to receive the MAPP1 data package, please contact us through your request to download the updated data package. The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network was established to focus on a broader approach to the study of Interstitial Cystitis (IC)/Painful Bladder Syndrome (PBS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men. Participants with some form or symptoms of IC or CP were asked to join the Trans-MAPP Epidemiology and Phenotyping (EP) Study. Participants with no Urologic Pelvic Pain Syndromes as well as participants with specific conditions (Fibromyalgia (FM), Irritable Bowel Syndrome (IBS), Chronic Fatigue Syndrome (CFS)) were recruited for the Trans-MAPP Control Study. These participants were a reference/control group for the Trans-MAPP EP Study.

A new study, TODAY2 Control Echocardiogram Sample Data Collection Study (TODAY2 ECHO), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. In the last year of the TODAY study, the cohort was assessed by echocardiography. A follow-up echocardiogram was completed 5 years later during the TODAY2 study. During TODAY2, the study also collected comparative echocardiogram control data in individuals without diabetes and hypertension, and also performed a one-time collection of data and blood for storage of serum and plasma in these consented control participants.

A new study, Treatment Options for Type 2 Diabetes in Adolescents & Youth Long Term Follow-Up (TODAY2), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The TODAY2 study was a longitudinal follow-up study to the TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study that continued the care and observation of the TODAY cohort participants beyond the end of the TODAY intervention trial. The TODAY2 study had two phases: 1) Transition of TODAY participants to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months, and 2) Long-term longitudinal follow-up of the TODAY cohort based on findings from TODAY.

Data have been updated for Look AHEAD: Action for Health in Diabetes (Look AHEAD). This update includes new and updated datasets for the intervention and post-intervention phases of the study. If you have already been approved to receive the Look AHEAD data package, please contact us through your request to download the updated data package. The Look AHEAD study was a clinical trial designed to assess whether an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity improves the long-term cardiovascular morbidity and mortality of overweight patients with type 2 diabetes.

A new study, SEARCH for Diabetes in Youth (SEARCH), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The SEARCH for Diabetes in Youth (SEARCH) study was initiated in 2000 to address major knowledge gaps in the understanding of childhood diabetes. The SEARCH study was conducted at five sites across the U.S. and established a longitudinal cohort to assess the natural history and risk factors for acute and chronic diabetes-related complications, as well as the quality of care and quality of life of persons with diabetes from diagnosis into young adulthood.

Data have been updated for the Long-Term Investigative Follow-Up in TrialNet Study (TN16 LIFT). This update includes a new dataset on health status in addition to updates to existing datasets. If you have already been approved to receive the TN16 data package, please contact us through your request to download the updated data package. The TN16 LIFT study is a clinical study that follows participants from TrialNet prevention studies after diagnosis with type 1 diabetes (T1D). The study follows individuals who developed diabetes while being monitored in the Pathway to Prevention Study or during participation in any prevention trial. The purpose is to study people early in the disease process. Additionally, the study follows individuals who participated in any new onset studies to learn more about diabetes and if there are any long-term effects from the treatments used in those studies.

Data have been updated for the HALT Progression of Polycystic Kidney Disease (HALT PKD). This update includes an additional dataset containing HALT PKD allele frequencies. If you have already been approved to receive the HALT PKD data package, please contact us through your request to download the updated data package. The HALT Progression of Polycystic Kidney Disease (HALT PKD) studies are two simultaneous multicenter clinical trials designed to test the efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and the decline in renal function in autosomal dominant polycystic kidney disease (ADPKD). Specifically, the studies test the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in hypertensive ADPKD subjects.

Data have been updated for the Chronic Renal Insufficiency Cohort Study (CRIC). This update includes updated datasets and additional analysis and raw datasets. If you have already been approved to receive the CRIC data package, please contact us through your request to download the updated data package. The Chronic Renal Insufficiency Cohort (CRIC) Study is an observational study that examined risk factors for progression of chronic renal insufficiency (CRI) and cardiovascular disease (CVD) among CRI patients. The study enrolled adults aged 21 to 74 years with a broad spectrum of renal disease severity, half of whom were diagnosed with diabetes mellitus. Subjects underwent extensive clinical evaluation at baseline and at annual clinic visits and via telephone at 6 month intervals.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M162 and M238. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of type 1 diabetes (T1D). The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

Data have been updated for the TrialNet Pathway to Prevention (TN01) study. This update includes study data through 2020. If you have already been approved to receive the TN01 data package, please contact us through your request to download the updated data package. TrialNet is a network of 19 clinical centers worldwide that conducts research on the study, prevention, and early treatment of type 1 diabetes (T1D). The TrialNet Pathway To Prevention (TN01) is a screening and monitoring study that was established to provide a source of subjects for enrollment into prevention trials.

Data have been updated for the Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP). This update includes an additional dataset containing CRISP allele frequencies. If you have already been approved to receive the CRISP data package, please contact us through your request to download the updated data package. The Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) was established to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of progression of renal disease in patients with polycystic kidney disease.

Data have been updated for the Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus (TN07) study. This update includes the final datasets for the TN07 study. If you have already been approved to receive the TN07 data package, please contact us through your request to download the updated data package. The TN07 study was a clinical trial that assessed the efficacy of oral insulin in the prevention or delay of the development of type 1 diabetes mellitus in subjects with mIAA and other autoantibodies and a proband with type 1 diabetes.

A new study, JDRF Follow-Up of Children Diagnosed with Diabetes (JDRF-TEDDY Follow-Up), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The JDRF Follow-up of Children Diagnosed with Diabetes (JDRF-TEDDY Follow-Up) study sought to understand whether children were diagnosed at an earlier stage of T1D compared to children not enrolled in prospective studies, and to identify if they maintained the ability to produce C-peptide longer than children diagnosed through standard clinical care in the community. The JDRF-TEDDY Follow-Up study analyzed the preservation of C-peptide over time in children diagnosed with T1D through prospective studies and compared them to a group of age matched controls identified from the community.

Data have been updated for Novel Therapies to Treat Resistant Focal Segmental Glomerulosclerosis: Phase II Clinical Trial (FSGS/FONT). This update includes a new ancillary dataset containing FSGS APOL1 genotypes. If you have already been approved to receive the FSGS/FONT data package, please contact us through your request to download the updated data package. The FSGS Clinical Trial (FSGS-CT) was a multi-center, prospective, controlled, open label randomized trial designed to determine if treatment with mycophenolate mofetil (MMF) in conjunction with pulse steroids is superior to treatment with Cyclosporine-A (CSA) in inducing remission from proteinuria over 12 months.

Data have been updated for The Diabetes Prevention Program (DPP). This update includes a new dataset containing additional measures (age, weight, and BMI) from study baseline. If you have already been approved to receive the DPP data package, please contact us through your request to download the updated data package. The Diabetes Prevention Program (DPP) is a clinical trial that investigated whether modest weight loss through dietary changes and increased physical activity or treatment with the oral diabetes drug metformin (Glucophage) could prevent or delay the onset of type 2 diabetes in high-risk individuals with prediabetes.

Data have been updated for The Chronic Kidney Disease in Children Cohort Study (CKiD). This update includes an additional analysis dataset (Pierce et al. AJE 2011) and follow-up data through July 31, 2018. If you have already been approved to receive the CKiD data package, please contact us through your request to download the updated data package. Chronic kidney disease (CKD) is a life-long condition that often results in substantial morbidity and premature death due to complications from a progressive decrease in kidney function. The early detection of, and initiation of therapy for, CKD is key to delaying or preventing progression to end-stage renal disease (ESRD). The CKiD study is a prospective cohort study of children with CKD that investigates risk factors and outcomes of the disease.

A new study, A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes (PERL), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The PERL Study was a double-blinded, international clinical trial conducted with patients with type 1 diabetes that had an increased risk of developing kidney disease. Participants were randomly assigned to take allopurinol or placebo for three years, during which they were followed through periodical visits. Kidney function was measured at the beginning and at the end of the treatment period to assess whether patients taking allopurinol experienced a slower loss of kidney function over time compared to those taking the placebo.

Data have been updated for the Folic Acid for Vascular Outcome Reduction in Transplantation Trial (FAVORIT). This update includes results of sample stability testing for a subset of biospecimens through multiple freeze/thaw cycles. If you have already been approved to receive the FAVORIT data package, please contact us through your request to download the updated data package. FAVORIT is a multicenter, randomized, double-blind clinical trial to determine whether total homocysteine (tHcy)-lowering treatment with a standard multivitamin augmented by a high dose combination of folic acid, vitamin B12, and vitamin B6, versus treatment with an identical multivitamin containing no folic acid and estimated average requirement (EAR) amounts of vitamin B6 and vitamin B12, reduces cardiovascular disease (CVD) outcomes among clinically stable renal transplant recipients (RTRs) with elevated tHcy levels.

Data have been updated for the Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes additional analysis datasets for M105 and M158. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of T1D. The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

A new study, Treatment Options for Type 2 Diabetes in Adolescents & Youth (TODAY) Genetics, has been posted to the NIDDK Central Repository. Data from this study are now available for request. The TODAY Genetics study was an ancillary study of the TODAY interventional trial conducted under the auspices of the TODAY study group. The primary objective of the TODAY Genetics study was to explore relationships between candidate genes and Type 2 Diabetes (T2D) using blood and phenotypic information collected from participants. In addition, the study investigated the role of Genetics in obesity, insulin resistance, and cardiac risk in T2D patients.

A new study, Time to Reduce Mortality in End-Stage Renal Disease (TiME) Trial, has been posted to the NIDDK Central Repository. Data from this study are now available for request. The TiME trial was a cluster-randomized, parallel-group pragmatic clinical trial for patients initiating treatment with maintenance hemodialysis. Facilities were randomized in a 1:1 distribution to the Intervention arm or the Usual Care arm. The primary objective of the TiME trial was to determine whether hemodialysis duration of a minimum of 4.25 hours (versus usual care) in patients with end-stage renal disease has benefits on mortality, hospitalizations, and health-related quality of life. The TiME trial also aimed to demonstrate the capacity to conduct large, pragmatic clinical trials with two large dialysis provider organizations.

Data have been updated for the Look AHEAD: Action for Health in Diabetes study. This update contains data from the Look AHEAD Continuation Study (Look AHEAD-C), which builds on the Look AHEAD study to determine the long-term impact of an intensive lifestyle intervention on 1) physical function and mobility disability, and 2) cognitive function and cognitive impairment. Collection of cognitive function measures began in Year 8 of the study and continued through Year 13. If you have already been approved to receive the Look AHEAD data package, please contact us through your request to download the updated data package. The Look AHEAD study was a clinical trial designed to assess whether an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity improves the long-term cardiovascular morbidity and mortality of overweight patients with type 2 diabetes.

Data have been updated for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. This update includes an additional analysis dataset (EDIC Year 24 Microvascular CVD) and raw data for EDIC years 19 through 24. If you have already been approved to receive the DCCT/EDIC data package, please contact us through your request to download the updated data package. The Diabetes Control and Complications Trial (DCCT) was a multicenter, randomized clinical trial designed to compare intensive with conventional diabetes therapy with regard to their effects on the development and progression of the early vascular and neurologic complications of type 1 insulin-dependent diabetes mellitus. The Epidemiology of Diabetes Interventions and Complications (EDIC) study was initiated as follow-up to examine the long-term effects of the original DCCT interventions on diabetic complications such as cardiovascular events and advanced retinal and renal disease.

Data have been updated for the Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes an additional analysis dataset (M123) and a dataset containing results from TEDDY OLINK analysis. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of T1D. The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

A new study, Hyperglycemia and Adverse Pregnancy Outcomes Follow-Up Study (HAPO-FUS), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The HAPO Follow-up Study was initiated to determine whether elevated blood sugar during pregnancy, below the threshold for gestational diabetes, influences either development of type 2 diabetes mellitus in mothers or adiposity and disorders of glucose metabolism in offspring at 8-12 years of age. The HAPO Follow-Up Study enrolled 7,000 mother-child pairs who originally participated in the HAPO Study. Mothers and children were required to complete a single study visit for measurement of height, weight, blood pressure, body fat, insulin, and blood sugar and lipid levels. The primary outcome measures assessed in relation to maternal glycemia during pregnancy were development of diabetes in mothers and obesity and altered glucose metabolism in children, as well as other metabolic abnormalities in both mothers and offspring.

Data have been updated for the Look AHEAD: Action for Health in Diabetes study. This update contains data from an ancillary study, Look AHEAD Brain, which aimed to assess whether participation in the 10-year lifestyle intervention, as part of Look AHEAD, had an impact on white matter hyperintensity and loss of brain tissue among individuals with type 2 diabetes. A subset of Look AHEAD study participants underwent standardized brain magnetic resonance imaging in conjunction with tests assessing cognitive function 10-12 years post-randomization. If you have already been approved to receive the Look AHEAD data package, please contact us through your request to download the updated data package. The Look AHEAD study was a clinical trial designed to assess whether an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity improves the long-term cardiovascular morbidity and mortality of overweight patients with type 2 diabetes.

Data have been updated for the Longitudinal Assessment of Bariatric Surgery (LABS) study. This update contains data from an ancillary study regarding psychosocial issues associated with bariatric surgery. This ancillary prospective cohort study aimed to understand the mental health impacts of bariatric surgery and changes in mental health outcomes over a 7-year follow-up period. Data were collected on psychosocial issues such as eating disorders, substance abuse, affective disorders, and cognitive function. If you have already been approved to receive the LABS data package, please contact us through your request to download the updated data package. The LABS study was an observational study designed to assess the risks and health benefits associated with bariatric surgery and to identify aspects of the procedures and patient characteristics associated with optimal outcomes.

Data have been updated for the Diabetes Prevention Program (DPP) study. This update contains supplemental measurements using biospecimens that were obtained during the original DPP clinical trial. These measurements include antibodies, biomarkers, hormones, and vitamin D levels to assess the relationships between sex hormones, diabetes risk factors, and the progression to diabetes. If you have already been approved to receive the DPP data package, please contact us through your request to download the updated data package. The Diabetes Prevention Program (DPP) is a clinical trial that investigated whether modest weight loss through dietary changes and increased physical activity or treatment with the oral diabetes drug metformin (Glucophage) could prevent or delay the onset of type 2 diabetes in high risk individuals with prediabetes.

A new study, FibroScan in Pediatric Cholestatic Liver Disease (FORCE), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The FORCE study was a cross-sectional and longitudinal assessment of the utility of liver stiffness measurement (LSM) in children with chronic cholestatic liver disease. FORCE participants were also enrolled in the PROBE, BASIC, or LOGIC studies, and were evaluated for a period of up to 24 months to assess the non-invasive ultrasound tool (FibroScan™) to detect and quantify global liver fibrosis in children with biliary atresia (BA), alpha-1 antitrypsin deficiency (A1ATD), and Alagille syndrome (ALGS). Baseline data are currently available.

A new study, Restoring Insulin Secretion – Pediatric Medication Study (RISE Pediatric Medication), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The RISE Pediatric Medication Study was a two-arm, multi-center clinical trial. Study participants were enrolled at four recruitment centers and randomized into two treatment groups. The first group received metformin alone for 12 months. The second group received glargine, a man-made insulin, for three months followed by metformin for the remaining nine months of the treatment period. Beta-cell function and insulin sensitivity were assessed at baseline, the end of the active treatment period, and three months after treatment was withdrawn.

Data have been updated for the Environmental Determinants of Diabetes in the Young (TEDDY) study. This update includes two additional analysis datasets (M62 and M237). If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of T1D. The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

A new study, Beta Cell Restoration Through Fat Mitigation (BetaFat), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The Beta Cell Restoration Through Fat Mitigation (BetaFat) study was created to determine if weight loss through gastric banding surgery would be more effective than metformin medication at sustaining or improving beta-cell function in individuals with prediabetes or early type 2 diabetes, who are also mildly to moderately obese.

A new study, Restoring Insulin Secretion - Adult Medication Study (RISE Adult Medication), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The RISE Adult Medication Study was a partially double-blind, placebo-controlled, four-arm clinical trial. Study participants were randomized into four groups and received treatment for 12 months. During the treatment period, the first group received Metformin alone; the second group received Glargine for three months, followed by Metformin for the remaining nine months; the third group received Liraglutide in combination with Metformin; and the fourth group was treated with placebo. Following the 12-month treatment period, each group underwent treatment withdrawal for three months. Insulin sensitivity and beta-cell function was evaluated at baseline, the end of the treatment period, and the end of the withdrawal period.

A new study, Assessment, Serial Evaluation, and Subsequent Sequelae in Acute Kidney Injury (ASSESS-AKI), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The Assessment, Serial Evaluation, and Subsequent Sequelae of Acute Kidney Injury (ASSESS-AKI) Study investigates differences in the occurrence of renal and cardiovascular outcomes and death within a diverse, matched cohort of patients with and without acute kidney injury (AKI). This prospective study enrolls a cohort of 1100 adult participants with a broad range of AKI and matched hospitalized participants without AKI at 3 Clinical Research Centers, as well as 100 children undergoing cardiac surgery at 3 Clinical Research Centers. Participants are followed for up to four years, and undergo serial evaluation during the index hospitalization, at three months post-hospitalization, and at annual clinic visits, with telephone interviews occurring during the intervening six-month intervals. Biospecimens are collected at each visit, in addition to information on lifestyle behaviors, quality of life and functional status, cognitive function, receipt of therapies, interim renal and cardiovascular events, electrocardiography, and urinalysis.

A new study, Gut Microbiome and p-Inulin in CKD - TarGut CKD Study (TarGut), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The Gut Microbiome and p-Inulin in CKD (TarGut) Study was formed to determine if the gut microbiome of patients with CKD could be improved with treatment of p-inulin, a type of prebiotic. After recruitment and enrollment, TarGut participants are evaluated for a period of 28 weeks. This 28-week study period consists of three phases: an 8-week pre-treatment phase, 12-week active treatment phase, and 8-week post-treatment phase. During the active treatment phase participants take the p-inulin supplement daily, but participants don’t receive any intervention during the pre- and post-treatment phases. Biological samples are collected from study participants every week during the 28-week study period and assessed to determine microbial composition and function.

Data have been updated for the African American Study of Kidney Disease and Hypertension Study (AASK Trial) study. Additional lab data have been added to the data package. If you have already been approved to receive the AASK Trial data package, please contact us through your request to download the updated data package. The African American Study of Kidney Disease and Hypertension study (AASK Trial) was a multi-center, randomized clinical trial that investigated the effects of blood pressure (BP) control and the use of specific antihypertensive regimens on the progression of chronic kidney disease (CKD). The study was designed to address the high incidence of CKD in African Americans with hypertension. A two by three factorial study design, including two levels of BP control as defined by mean arterial pressure (MAP) and three different anti-hypertensive regimens, was used. Participants were randomized into two levels of BP control groups, either a goal MAP < 92 mmHg or a goal MAP between 102-107 mmHg inclusive.. The antihypertensive drugs used for treatment were amlodipine, a calcium channel blocker; ramipril, an angiotensin-converting enzyme inhibitor; and metoprolol, a β-blocker. The trial was double-blind (drug administration only). The change in glomerular filtration rate (GFR) as determined by iothalamate clearance was measured as the primary outcome to test the regimens’ efficacy in slowing the rate of decline of kidney function.

Data have been updated for the Modification of Diet in Renal Disease (MDRD) study. Additional lab data have been added to the data package. If you have already been approved to receive the MDRD data package, please contact us through your request to download the updated data package. The Modification of Diet in Renal Disease (MDRD) study consisted of two randomized clinical trials that investigated whether protein restriction and control of blood pressure had an effect on the progression of chronic kidney disease (CKD). The study tested two hypotheses—that (1) a reduction in dietary protein and phosphorous intake and (2) the maintenance of blood pressure at a level below that usually recommended safely and effectively delays the progression of CKD.

A new study, Aprepitant for the Relief of Nausea in Patients With Chronic Nausea and Vomiting of Presumed Gastric Origin Trial (APRON), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. The Aprepitant for the Relief of Nausea in Patients with Chronic Nausea and Vomiting of Presumed Gastric Origin (APRON) study is a multicenter, randomized, placebo-controlled clinical trial designed to test the safety and efficacy of aprepitant in reducing symptoms among patients with gastroparesis.

Data have been updated for the DILIN Retrospective study. Data through the grant 3 cycle (2018) are now available. If you have already been approved to receive the DILIN Retrospective data package, please contact us through your request to download the updated data package. Drug-induced liver injury (DILI) is the single most common reason for regulatory actions concerning drugs, including failure to gain approval for marketing, removal from the market place, and restriction of prescribing indications. DILI is also a significant cause of morbidity and mortality in many patient populations. To stimulate and facilitate research into DILI, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has recently established the Drug-Induced Liver Injury Network (DILIN). One of the initial projects to be conducted by the network is to retrospectively establish a nationwide registry of patients who have suffered severe idiosyncratic liver injury associated with drugs (ILIAD), and to collect, and store serum, DNA from these patients (hereafter referred to as the “ILIAD protocol”). This ILIAD protocol will serve as a resource for subsequent mechanistic investigations of the basis for susceptibility to severe idiosyncratic DILI.

Data have been updated for the DILIN Prospective study. Data through the grant 3 cycle (2018) are now available. If you have already been approved to receive the DILIN Prospective data package, please contact us through your request to download the updated data package. The DILIN prospective study is an ongoing multicenter observational study. Patients (2 years of age or older) were enrolled in this study if there was a strong clinical suspicion that a liver injury event was caused by a medication or an herbal agent occurring within 6 months before enrollment. Additionally, patients must meet one of the biochemical criteria for enrollment into this study.

Data have been updated for the Chronic Renal Insufficiency Cohort (CRIC) study. Additional variables have been added to the derived datasets. The Chronic Renal Insufficiency Cohort (CRIC) Study is an observational study that examined risk factors for progression of chronic renal insufficiency (CRI) and cardiovascular disease (CVD) among CRI patients. The study enrolled adults aged 21 to 74 years with a broad spectrum of renal disease severity, half of whom were diagnosed with diabetes mellitus. Subjects underwent extensive clinical evaluation at baseline and at annual clinic visits and via telephone at 6 month intervals. Data on quality of life, dietary assessment, physical activity, health behaviors, depression, cognitive function, health care resource utilization, as well as blood and urine specimens were collected. Measures of kidney function and occurrence of new and worsening CVD are the primary outcomes, among others.

Data have been updated for the Farnesoid X Receptor Ligand Obeticholic Acid in NASH Treatment (FLINT) study. The data package now includes the form data for the study. If you have already been approved to receive the FLINT data package, please contact us through your request to download the updated data package. The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in Nonalcoholic Steatohepatitis (NASH) Treatment (FLINT) trial was a multicenter, randomized, placebo-controlled clinical trial conducted by the NASH CRN to investigate the safety and efficacy of treatment of obeticholic acid compared to placebo in adults with nonalcoholic fatty liver disease.

Data have been updated for the Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT) study. The data package now includes the form data for the study. If you have already been approved to receive the GLUMIT data package, please contact us through your request to download the updated data package. The Safety, Feasibility, and Potential Efficacy of Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG) study is a multicenter, uncontrolled clinical trial that was established by the Gastroparesis Clinical Research Consortium (GpCRC) to assess the safety and utility of CGM in guiding insulin pump therapy in patients with type 1 and type 2 diabetes and gastroparesis.

Data have been updated for the Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children (CyNCh) study. The data package now includes the form data for the study. If you have already been approved to receive the CyNCh data package, please contact us through your request to download the updated data package. The CyNCh (Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children) study is a prospective, multicenter, double-blind clinical trial designed by the NASH Clinical Research Network to determine whether treatment with cysteamine improves disease severity in children diagnosed with NAFLD. Children between the ages of 8 and 17 years with biopsy-confirmed moderate to severe NAFLD were eligible for the CyNCh study. Participants were enrolled and randomized to treatment with either delayed-release cysteamine bitartrate capsules or placebo capsules. Improvement in NAFLD at 52 weeks, defined as a decrease in NAFLD Activity Score (NAS) of at least 2 and no worsening of fibrosis, was assessed as the primary outcome measure. Secondary outcome measures, assessed at 52 weeks, included reduction in serum aminotransferase and gamma-glytamyl transpeptidase, reduction in MRI-determined hepatic fat fraction, changes in markers of oxidation and anti-oxidant status, changes in histology and symptoms, and self-reported quality of life.

Data have been updated for the Adolescent Bariatrics: Assessing Health Benefits & Risks (Teen-LABS) study. The data package now includes additional analysis datasets through Year 4. The objective of the Teen-LABS study is to use standardized techniques to assess the short and longer-term safety and efficacy of bariatric surgery in adolescents compared to adults.

A new study, The CKD Optimal Management With BInders and NicotinamidE (COMBINE), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. In people with chronic kidney disease, kidneys struggle to get rid of enough phosphorus, so FGF23 levels increase in the blood to help get rid of extra phosphorus. Over time, with progressive loss of kidney function, both phosphorus and FGF23 can build up in the blood simultaneously. Researchers believe that too much phosphorus and FGF23 in the blood may lead to weak bones, increase the risk of heart problems, and accelerate progression of kidney disease. However, the best way to control phosphorus and FGF23 levels in the blood in patients with chronic kidney disease is not known. COMBINE is a study to determine new methods to lower serum phosphorus levels and levels of FGF23 in chronic kidney disease patients.

A new study, Bicarbonate Administration to Stabilize Estimated Glomerular Filtration Rate (eGFR) (BASE), has been posted to the NIDDK Central Repository. Data and biospecimens from this study are now available for request. Sodium bicarbonate may help prevent kidney failure in people with chronic kidney disease. However, the dose to prescribe in order to test this possibility in a clinical trial is uncertain. The BASE pilot clinical trial hoped to determine the best dose of sodium bicarbonate to prescribe in a future study that will test the long-term safety and efficacy of sodium bicarbonate as a treatment to preserve kidney function in individuals with chronic kidney disease.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY). This update includes additional analysis datasets from the M176 publication as well as the updated questionnaire data through December 2018. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of T1D. The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

Data have been updated for the Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) study. The data package now includes data through the CRISP 3 cycle. If you have already been approved to receive the CRISP data package, please contact us through your request to download the updated data package. The Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease (CRISP) was established to develop and implement studies to test whether imaging techniques can provide accurate and reproducible markers of progression of renal disease in patients with polycystic kidney disease. Autosomal-dominant polycystic kidney disease (ADPKD) is characterized by gradual renal enlargement and cyst growth prior to loss of renal function; however, standard radiographic imaging has not provided the resolution and accuracy necessary to detect small changes in renal volume or to reliably measure renal cyst volumes. The CRISP cohort study longitudinally observed ADPKD individuals using high-resolution magnetic resonance (MR) imaging to determine if change in renal and cyst volumes can be detected over a short period of time, and if they correlate with decline in renal function early in disease.

Data have been updated for the Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC) study. This study is part of the Childhood Liver Disease Research Network (ChiLDReN). Analysis data from a publication by Dr. Kamath are now available for request. If you have already been approved to receive the LOGIC data package, please contact us through your request to download the updated data package. The primary objectives of the LOGIC study include determining the frequency of poor growth and decreased bone mineral density and its predictors; identifying modifier genes that influence the incidence, severity, and progression of liver disease among affected individuals; and developing a repository of biospecimens to be used in ancillary studies of predictor biomarkers.

Data have been updated for the A Prospective Database of Infants With Cholestasis (PROBE) study. This study is part of the Childhood Liver Disease Research Network (ChiLDReN). Analysis data from a publication by Dr. Squires are now available for request. PROBE is a multi-center project that established a prospective database of clinical information and a repository of blood and tissue samples from children with diagnoses of neonatal liver diseases, such as biliary atresia and neonatal hepatitis, in order to perform research in these liver problems. Children were screened and enrolled at presentation at the participating pediatric liver sites. Subjects diagnosed with biliary atresia were followed intensively for the first year, at 18 months of age, and then annually up to 15 years of age. Other subjects diagnosed with cholestasis were followed on the same schedule; if there was complete (clinical and biochemical) resolution of their underlying liver disease off all therapy, there was one follow up visit within one year (preferably scheduled at the time of the next planned follow up visit or at 12 months of age, whichever was later) for data collection and to obtain blood samples. The development of a serum and tissue bank of specimens from children with various neonatal cholestatic disorders are used for future investigations into the etiology and pathogenesis of hepatobiliary injury in the infant.

Data have been updated for the TrialNet 10 Anti-CD3 Prevention (TN10 Anti-CD3 Prevention). Teplizumab (Anti-CD3) is a monoclonal antibody that interferes in the autoimmune attack of pancreatic beta cells. Previous studies have shown that teplizumab reduces the loss of insulin production in type 1 diabetics during the first year after diagnosis. TrialNet 10 is a phase 2 prevention trial of TrialNet, studying the effect of teplizumab on insulin production in the relatives of type 1 diabetics who are at high risk of developing the disease. TrialNet 10 is projected to last 4-6 years with an enrollment period of 2-3 years. The approximate enrollment of the study is 140-170 individuals between the ages of 8-45 years. Subjects will be randomly assigned to either the active or placebo group of the study, and monitored and tested over time until diagnosed with diabetes.

A new study, Hemodialysis Fistula Maturation (HFM), has been posted to the NIDDK Central Repository. Analysis datasets from the baseline visit are now available for request. Data and biospecimens from this study are now available for request. The Hemodialysis Fistula Maturation Study was a prospective, multicenter observational study that was established by the Hemodialysis Fistula Maturation Consortium (HFMC) to identify the clinical and biological factors associated with AVF maturation outcomes. The primary objectives of the study included improving prediction of AVF maturation and exploring the mechanism of AVF failure by examining the relationship between clinical usability and anatomy, biology, clinical attributes, and processes of care.

Data have been updated for the Look AHEAD: Action for Health in Diabetes study. The data package now contains data through the end of the post intervention program. If you have already been approved to receive the Look Ahead data package, please contact us through your request to download the updated data package. The primary objective of the Look AHEAD study was to test whether an intensive lifestyle intervention program designed to achieve and maintain weight loss by decreased caloric intake and increased physical activity improves the long-term cardiovascular morbidity and mortality of overweight patients with type 2 diabetes.

A new study, Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis Liver Disease (PUSH), has been posted to the NIDDK Central Repository. Analysis datasets from the baseline visit are now available for request. PUSH is a prospective longitudinal study that aims to determine the utility of abdominal ultrasound to predict the development of cirrhosis in patients with cystic fibrosis. Participants will undergo abdominal ultrasound at enrollment and, based on the outcome, will be placed in one of four groups. Within a five year period subjects will undergo other sample collection procedures in addition to abdominal ultrasound. This study will also monitor the effects of cystic fibrosis on associated pulmonary and nutritional issues.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY). This update includes additional analysis datasets from the M64 publication. If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of T1D. The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

A new study, Symptoms of Lower Urinary Tract Dysfunction Network (LURN), has been posted to the NIDDK Central Repository. Data, biospecimens, and images from this study are now available for request. The Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study (LURN) was established to gain a better understanding of lower urinary tract symptoms in an effort to improve the lives of those with LUTD. LURN participants were enrolled at multiple sites within the United States. Patients were assigned to one of four subgroups, based on their symptoms, the outcomes of clinical assessments, and other characteristics. Biological samples were collected from study participants and patients were required to complete certain assessments and examinations at standard time-points during the study period. The purpose of the Symptoms of Lower Urinary Tract Dysfunction Phenotyping Study was to develop a framework for identifying and defining the subtypes of LUTS; create new questionnaires in order to improve the measurement of patient experiences of LUTS; and generate and share data, tools, and biological samples with clinical and research communities, in an effort to advance the understanding of LUTS and improve patients’ lives.

Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY). This update includes eight additional analysis datasets (M65, M68, M90a, M104, M111, M128, M142, and M224). If you have already been approved to receive the TEDDY data package, please contact us through your request to download the updated data package. The TEDDY study is a multicenter prospective cohort study that was established in response to these gaps in understanding of T1D. The primary objectives of the study include identifying environmental factors—such as infectious agents, dietary factors, and psychosocial factors—that trigger or protect against the development of islet autoimmunity and T1D and examining genetic-environmental interactions to investigate interactive effects that contribute to T1D.

Five new studies (CIT02-CIT-06) from the Clinical Islet Transplantation Consortium (CITC) have been posted to the NIDDK Central Repository and is available for request. The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets.

A new study, Irritable Bowel Syndrome Outcome Study (IBSOS), has been posted to the NIDDK Central Repository. Data from this study are now available for request. The Irritable Bowel Syndrome Outcome Study (IBSOS) sought to address the limitations of standard therapist-administered CBT by developing an effective self-administered version of the treatment method. IBSOS participants were randomized into one of three treatment groups and underwent four weeks of symptom monitoring. One group received the standard ten sessions of clinic-based CBT, one group received four sessions of minimal-contact CBT, and the remaining group received four sessions of supportive counseling and education without any prescribed behavior changes. Following the symptom monitoring phase, patients underwent treatment and follow-up phases. Assessments were regularly conducted during the study and the results were evaluated between the groups.