TODAY Genetics Study

Completed

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT00722397

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

2654

Starts

2008-08-01

Expected to finish

2015-02-01

Last updated by the study team

2021-08-04

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour oral glucose tolerance test (OGTT) glucose ≥ 200 mg/dL) documented and confirmed in medical record or a laboratory determination of HbA1c ≥ 7%. For asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an OGTT, the HbA1c must be ≥ 6%.
• BMI ≥ 85th percentile documented at time of diagnosis or at screening.
• Age < 18 at time of diagnosis.
• Signed informed consent and assent forms as appropriate.

You may not qualify if…

• Genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
• 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
• inhaled steroids at dose above 1000 mcg daily fluticasone equivalent,
• oral glucocorticoids,
• antirejection or chemotherapy agents (e.g., tacrolimus, L-asparaginase),
• atypical antipsychotics.

Where it is running

• UAMS Arkansas Children's Hospital — Little Rock, Arkansas, United States
• Childrens Hospital Los Angeles — Los Angeles, California, United States
• UCSD Rady Children's Hospital — San Diego, California, United States
• University of Colorado Denver — Aurora, Colorado, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• University of Florida — Gainesville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• George Washington University Biostatistics Center — Rockville, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• Kansas City Children's Mercy Hospital — Kansas City, Missouri, United States
• St Louis University — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Columbia University — New York, New York, United States
• State University of New York Upstate Medical University — Syracuse, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Texas Tech University Health Science Center — Lubbock, Texas, United States
• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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