TODAY Genetics Study

NCT ID: NCT00722397

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2654 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2015-02-28

Brief Summary

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.

Conditions

Type 2 Diabetes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

1. inhaled steroids at dose above 1000 mcg daily fluticasone equivalent,

2. oral glucocorticoids,

3. antirejection or chemotherapy agents (e.g., tacrolimus, L-asparaginase),

4. atypical antipsychotics.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phil Zeitler, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Kathryn Hirst, PhD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

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

Countries

United States

References

Srinivasan S, Chen L, Todd J, Divers J, Gidding S, Chernausek S, Gubitosi-Klug RA, Kelsey MM, Shah R, Black MH, Wagenknecht LE, Manning A, Flannick J, Imperatore G, Mercader JM, Dabelea D, Florez JC; ProDiGY Consortium. The First Genome-Wide Association Study for Type 2 Diabetes in Youth: The Progress in Diabetes Genetics in Youth (ProDiGY) Consortium. Diabetes. 2021 Apr;70(4):996-1005. doi: 10.2337/db20-0443. Epub 2021 Jan 21.

Reference Type: RESULT

PMID: 33479058 (View on PubMed)

Other Identifiers

DK61230

Identifier Type: -

Identifier Source: secondary_id

IND - DK61230-GENETICS

Identifier Type: -

Identifier Source: org_study_id