An observational study in Type 2 Diabetes, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 25 sites in United States. Per ClinicalTrials.gov, last updated 2021-08-04.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Observational
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 2,654 is above the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 529 studies on the registry; 54 are open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 50 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Recruitment is conducted within a 'catchment' area that includes (a) the patient pools of the 15 TODAY clinical centers and (b) collaborating clinics and physicians who either refer subjects to a TODAY site or obtain IRB approval to conduct the protocol at their own locale.
Exclusion Criteria:
Patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. If diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. Exclusionary medications include but are not limited to
Blood draw to be processed and analyzed to yield genetic data.
Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.
Time frame: Blood is drawn at the single study visit.
Phenotype data.
Demographic, medical history, and other data about participant and family, by self-report.
Time frame: Collected at single study visit.
Laboratory values.
Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory.
Time frame: Single study visit.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)