NIDDK Central Repository News
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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.
Data Update for PROBE (Study Page)
Data have been updated for the Prospective Database of Infants With Cholestasis (PROBE) study. The data package now includes an additional analysis dataset (Shneider) from a publication.
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 Update for GLUMIT (Study Page)
Analysis data are now available for request from the Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT) study.
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 TEDDY (Study Page)
Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY). This update includes eight additional analysis datasets (M180, M102, M45, M124, M74, M53, M113, and M38a).
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 TrialNet 01 (Study Page)
Data have been updated for the TrialNet Pathway To Prevention (formerly Natural History Study) (TN01 NH).
The primary aim of the study is to identify subjects for TrialNet prevention and investigation trials, but can also be used for assessing the predictive value of existing and novel risk markers of T1D, and for examining the demographic, immunologic, and metabolic characteristics of individuals at risk for developing T1D.
Data Update for START (Study Page)
Data have been updated for the Steroids in the Treatment of Biliary Atresia (START) study. The data package now includes analysis datasets (Bezerra) from a publication. START is a clinical trial with the objective to determine the efficacy of corticosteroids on the outcome of infants with biliary atresia.
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 analysis datasets (PedsQL) from a publication. 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: TrialNet07 (Study Page)
A new study, Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus (TN07), has been posted to the NIDDK Central Repository and is available for request. TN07 was a randomized clinical trial with the goal to assess 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.
Data Update for PROBE Study (Study Page)
Data have been updated for the Prospective Database of Infants With Cholestasis (PROBE) study. The data package now includes an additional analysis dataset (Superina) from a publication. 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 Update for CKiD Study (Study Page)
Data have been updated for the Chronic Kidney Disease in Children (CKiD) study. The data package now includes data through December 2015. The CKiD study is a prospective cohort study of children with chronic kidney disease (CKD) that investigates risk factors and outcomes of the disease. The CKiD study had various objectives, including: (1) identifying and quantifying novel and traditional risk factors for progression of CKD; (2) characterizing how CKD progression effects neurodevelopment, cognitive abilities, and behavior; (3) describing the prevalence of cardiovascular disease and associated risk factors; and (4) examining the effects of declining kidney function on growth in children with CKD.
New Study: STONE (Study Page)
A new study, The Study of Tamsulosin for Urolithiasis in the Emergency Department (STONE), has been posted to the NIDDK Central Repository and is available for request. STONE study was a clinical trial with the objective to determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients.
Specimens and Updated Data Available For CIT-07 (Study Page)
Specimens and updated data are available to be requested for the Islet Transplantation in Type 1 Diabetes (CIT-07) study. See the Data Dictionary included on the study page for a complete list of datasets that are available for request.
The Islet Transplantation in Type 1 Diabetes (CIT-07) study is a prospective, multicenter, single-arm clinical trial that was conducted by the CITC to investigate the safety and efficacy of islet transplantation when combined with an immunosuppressive medication regimen for treating type 1 diabetes in individuals with hypoglycemia unawareness. Individuals with type 1 diabetes with type 1 diabetes, dependence on insulin for at least 5 years at study entry, and at least one episode of severe hypoglycemia in the past 12 months were eligible for enrollment.
Data Update for TrialNet 01 (Study Page)
Data have been updated for the TrialNet Pathway To Prevention (formerly Natural History Study) (TN01 NH). The research labs dataset has been updated and split into two datasets.
The primary aim of the study is to identify subjects for TrialNet prevention and investigation trials, but can also be used for assessing the predictive value of existing and novel risk markers of T1D, and for examining the demographic, immunologic, and metabolic characteristics of individuals at risk for developing T1D.
Data Update for TEDDY (Study Page)
Data have been updated for The Environmental Determinants of Diabetes in the Young (TEDDY). This update includes form data as well as five additional analysis datasets (M24. M54, M56, M57, and M77).
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.