NIDDK Central Repository News
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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.
Data Update for TEDDY (Study Page)
Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY). This update includes one analysis dataset (M112) and the dietary biomarker data.
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 DCCT/EDIC (Study Page)
Data have been updated for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. The data package now includes Glycemic Variation (glyc_var) analysis data.
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.
New Study: PALF (Study Page)
A new study, Pediatric Acute Liver Failure (PALF), has been posted to the NIDDK Central Repository. Both data and biospecimens are now available for request.
The mission of the Pediatric Acute Liver Failure (PALF) study was to develop methods to predict whether a child will require a life-saving procedure in order to recover from acute liver failure.
Data Update for DCCT/EDIC (Study Page)
Data have been updated for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. The data package now includes the Optimal Frequency of Retinopathy (Optimret) analysis data.
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 Update for EPISOD (Study Page)
Data have been updated for the Evaluating Predictors and Interventions in Sphincter of Oddi Dysfunction (EPISOD). Data from the follow-up period are now available for request.
The EPISOD trial is a parallel, randomized, double-blinded, sham-controlled, multicenter Phase III clinical trial of endoscopic sphincterotomy as treatment for adults 18 to 65 years of age diagnosed with SOD III.
Data Update for CRIC (Study Page)
Data have been updated for the Chronic Renal Insufficiency Cohort (CRIC) study. Data from CRIC Phase 3 are now available. Additional data from Phase 1 were updated.
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 LOGIC (Study Page)
Data have been updated for the Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC) study. The data package now includes two additional analysis datasets (Techman and DXA) from two publications.
LOGIC is a observational study with the objectives to determine the frequency of poor growth and decreased bone mineral density and its predictors; identify modifier genes that influence the incidence, severity, and progression of liver disease among affected individuals; and develop a repository of biospecimens to be used in ancillary studies of predictor biomarkers.
New Study: CureGN (Study Page)
A new study, Cure Glomerulonephropathy (CureGN), has been posted to the NIDDK Central Repository and is available for request. The data pacakge includes one analysis dataset from the IgA publication.
Cure Glomerulonephropathy Network (CureGN) is a multi-center consortium that seeks to establish an infrastructure for the advancement of glomerular disease studies. CureGN recruits and maintains a large and diverse population of glomerular disease patients. The study established a database of patients diagnosed with the following conditions: minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), membranous nephropathy (MN), and immunoglobulin A nephropathy (IgAN).
Data Update for TEDDY (Study Page)
Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY). This update includes seven additional analysis datasets (M106a, M127, M138, M160, M165a, M165b, M177).
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: CIT-01 (Study Page)
A new study, Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation (CIT-01), has been posted to the NIDDK Central Repository and is available for request.
CIT01 participants were randomized to study treatment including Low Molecular Weight Sulfated Dextran (LMW-DS) and study treatment without LMW-DS.The primary objective of this study was to evaluate the safety and efficacy of Low Molecular Weight Dextran Sulfate (LMW-DS) to enhance engraftment and prevent IBMIR in islet transplantation to Type 1 diabetic subjects. The secondary objective was to gather additional safety and efficacy information about the combination of Low Molecular Weight Sulfated Dextran with islet transplantation.
New Study: TrialNet19 (Study Page)
A new study, ATG-GCSF in New Onset Type 1 Diabetes (TN19), has been posted to the NIDDK Central Repository and is available for request. TN19 was a three-arm, 1:1:1 randomized, placebo controlled, double-blinded trial in which at least 28 subjects will receive active Anti-Thymocyte Globulin and Granulocyte colony-stimulating factor (ATG-GCSF), at least 28 subjects will receive ATG alone and at least 28 subjects will receive placebo alone within 100 days from diagnosis of Type 1 Diabetes (T1D). TrialNet researchers were testing whether ATG used alone or in combination with GCSF will help people continue to make some of their own insulin.
Data Update for TEDDY (Study Page)
Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY). This update includes three additional analysis datasets (M34, M109, and M21).
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.