TODAY Genetics Study
The TODAY study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (T2D), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. Participation in the genetics study includes a blood draw for analysis of diabetes type and DNA extraction, as well as collection of basic family and medical history. Appropriate informed consent and assent are obtained from all participants to extract DNA and send blood, genetic material, and medical history to the Central Repository of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH). The data are kept indefinitely by the Central Repository. The NIDDK will issue requests for proposals (RFP) throughout the scientific community for research that may help in the development of new diagnostic tests, new treatments, and new ways to prevent diabetes and other related comorbidities.
Type 2 Diabetes
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study|
- Blood draw to be processed and analyzed to yield genetic data. [ Time Frame: Blood is drawn at the single study visit. ] [ Designated as safety issue: No ]Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.
- Phenotype data. [ Time Frame: Collected at single study visit. ] [ Designated as safety issue: No ]Demographic, medical history, and other data about participant and family, by self-report.
- Laboratory values. [ Time Frame: Single study visit. ] [ Designated as safety issue: No ]Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory.
Biospecimen Retention: Samples With DNA
Collect 27 mL of blood to send (1) for extraction of DNA to the NIDDK Central Repository and (2) for measurement of glucose, C-peptide, and autoantibody analysis to a central blood laboratory.
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722397
|Contact: Kathryn Hirst, PhD||301-881-9260 ext firstname.lastname@example.org|
Show 25 Study Locations
|Principal Investigator:||Phil Zeitler, MD PhD||University of Colorado, Denver|
|Principal Investigator:||Kathryn Hirst, PhD||George Washington University|