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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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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 |
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Type 2 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: | February 2011 (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 | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Norma Castaneda 323-361-5627 nzcastaneda@chla.usc.edu | |
Principal Investigator: Mitchell Geffner, MD | |
United States, Colorado | |
University of Colorado | Recruiting |
Denver, Colorado, United States, 80045 | |
Contact: Amber Hull 720-777-4354 amber.hull@uchsc.edu | |
Principal Investigator: Phil Zeitler, MD PhD | |
United States, Connecticut | |
Yale University | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Contact: Cindy Guandalini 203-785-7817 cindy.gunadalini@yale.edu | |
Principal Investigator: Sonia Caprio, MD | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Elaine Javier 617-724-3504 ejavier@partners.org | |
Principal Investigator: David M Nathan, MD | |
Joslin Diabetes Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: Maureen Malloy 617-735-1919 ext 4461 maureen.malloy@joslin.harvard.edu | |
Principal Investigator: Lori Laffel, MD | |
United States, Missouri | |
Washington University | Recruiting |
St Louis, Missouri, United States, 63110 | |
Contact: Tracy Jones 314-286-1165 jones_t@kids.wustl.edu | |
Principal Investigator: Neil White, MD | |
St Louis University | Recruiting |
St Louis, Missouri, United States, 63104 | |
Contact: Theresa Whelan 314-577-5611 whelantm@slu.edu | |
Principal Investigator: Sherida Tollefsen, MD | |
United States, New York | |
State University of New York Upstate Medical University | Recruiting |
Syracuse, New York, United States, 13214 | |
Contact: Kelly Duncan 315-464-3878 duncank@upstate.edu | |
Principal Investigator: Ruth Weinstock, MD PhD | |
Columbia University | Recruiting |
New York, New York, United States, 10032 | |
Contact: Pat Kringas 212-851-5489 mpk40@columbia.edu | |
Principal Investigator: Robin Goland, MD | |
United States, Ohio | |
Case Western Reserve University | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Amy Schmidt 216-844-1966 abw7@case.edu | |
Principal Investigator: Leona Cuttler, MD | |
United States, Oklahoma | |
University of Oklahoma | Recruiting |
Oklahoma City, Oklahoma, United States, 73117 | |
Contact: Jill Schanuel 405-271-8001 ext 43075 jill-schanuel@ouhsc.edu | |
Principal Investigator: Ken Copeland, MD | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Lori Bednarz 412-692-6565 lori.bednarz@chp.edu | |
Principal Investigator: Silva Arslanian, MD | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Stephanie Kneeshaw-Price 267-234-8915 skneeshawprice@email.chop.edu | |
Principal Investigator: Lorraine Katz, MD | |
Sub-Investigator: Steve Willi, MD | |
United States, Texas | |
University of Texas Health Science Center | Recruiting |
San Antonio, Texas, United States, 78207 | |
Contact: Rose Ann Barajas 210-562-5227 barajasr@uthscsa.edu | |
Principal Investigator: Jane Lynch, MD | |
Sub-Investigator: Dan Hale, MD | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Sue McGirk 832-822-3063 tmcgirk@bcm.tmc.edu | |
Principal Investigator: Siripoom McKay, MD | |
Sub-Investigator: Morey Haymond, MD |
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 |
Study First Received: | July 23, 2008 |
Last Updated: | February 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00722397 History of Changes |
Health Authority: | United States: Federal Government |
genetics, pediatrics |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |