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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00722397 |
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.
Condition |
Type 2 Diabetes |
MedlinePlus related topics: | Diabetes |
Study Type: | Observational |
Study Design: | Case-Only, 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 |
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.
Estimated Enrollment: | 2500 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.
Inclusion Criteria:
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
Contact: Kathryn Hirst, PhD | 301-881-9260 ext 8025 | khirst@bsc.gwu.edu |
United States, California | |||||
Childrens Hospital Los Angeles | |||||
Los Angeles, California, United States, 90027 | |||||
United States, Colorado | |||||
University of Colorado | |||||
Denver, Colorado, United States, 80045 | |||||
United States, Connecticut | |||||
Yale University | |||||
New Haven, Connecticut, United States, 06519 | |||||
United States, Massachusetts | |||||
Massachusetts General Hospital | |||||
Boston, Massachusetts, United States, 02114 | |||||
Joslin Diabetes Center | |||||
Boston, Massachusetts, United States, 02215 | |||||
United States, Missouri | |||||
Washington University | |||||
St Louis, Missouri, United States, 63110 | |||||
St Louis University | |||||
St Louis, Missouri, United States, 63104 | |||||
United States, New York | |||||
State University of New York Upstate Medical University | |||||
Syracuse, New York, United States, 13214 | |||||
Columbia University | |||||
New York, New York, United States, 10032 | |||||
United States, Ohio | |||||
Case Western Reserve University | |||||
Cleveland, Ohio, United States, 44106 | |||||
United States, Oklahoma | |||||
University of Oklahoma | |||||
Oklahoma City, Oklahoma, United States, 73117 | |||||
United States, Pennsylvania | |||||
Children's Hospital of Pittsburgh | |||||
Pittsburgh, Pennsylvania, United States, 15213 | |||||
Children's Hospital of Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Texas | |||||
University of Texas Health Science Center | |||||
San Antonio, Texas, United States, 78207 | |||||
Baylor College of Medicine | |||||
Houston, Texas, United States, 77030 |
Principal Investigator: | Phil Zeitler, MD PhD | University of Colorado -- Denver |
Study Chair: | Francine Kaufman, MD | Children's Hospital Los Angeles |
Principal Investigator: | Kathryn Hirst, PhD | George Washington University |
Responsible Party: | George Washington University Biostatistics Center ( Kathryn Hirst/Coordinating Center Principal Investigator ) |
Study ID Numbers: | DK61230-GENETICS, DK61230 |
First Received: | July 23, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00722397 |
Health Authority: | United States: Federal Government |
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