NIDDK Central Repository News
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New Study: APRON (Study Page)
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 Update for DILIN Retrospective (Study Page)
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 Update for DILIN Prospective (Study Page)
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.
NIDDK R21 for Secondary Data Analysis
NIDDK has posted an opportunity for those using secondary data in new analyses. The eligible data includes that which can be requested via the repository website. For additional details on the opportunity, see the NIH grant page.
Data Update for CRIC (Study Page)
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 Update for FLINT (Study Page)
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 Update for GLUMIT (Study Page)
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 Update for CyNCH (Study Page)
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 Update for Teen-LABS Study (Study Page)
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.
New Study: COMBINE (Study Page)
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.
New Study: BASE (Study Page)
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 Update for TEDDY (Study Page)
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 Update for CRISP (Study Page)
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 Update for LOGIC (ChiLDReN) (Study Page)
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 Update for PROBE (ChiLDReN) (Study Page)
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 Update for TrialNet 10 (Study Page)
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.
New Study: HFM (Study Page)
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 Update for Look AHEAD (Study Page)
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.
New Study: PUSH (ChiLDReN) (Study Page)
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 Update for TEDDY (Study Page)
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.
New Study: LURN (Study Page)
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 Update for TEDDY (Study Page)
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.
New Studies: CIT-02-CIT-06 (Study Page)
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.
New Study: IBSOS (Study Page)
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.
Data Update for CRIC (Study Page)
Data have been updated for the Chronic Renal Insufficiency Cohort (CRIC) study. Additional data through 2018 from Phase 1 and Phase 3 are now available.
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.