NIDDK Central Repository News
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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.