TODAY Genetics Study

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722397
• Other study ID #: IND - DK61230-GENETICS
• Secondary ID: DK61230
• Status: Completed
• Start date: August 2008
• Est. completion date: February 2015

Study information

• Verified date: July 2021
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2654
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Blood is drawn at the single study visit.
Secondary	Phenotype data.	Demographic, medical history, and other data about participant and family, by self-report.	Collected at single study visit.
Secondary	Laboratory values.	Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory.	Single study visit.