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TODAY Genetics Study
This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), February 2009
First Received: July 23, 2008   Last Updated: February 23, 2009   History of Changes
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
  Purpose

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
U.S. FDA Resources
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

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Diabetes by ADA criteria (laboratory determinations of fasting glucose ≥ 126 mg/dL, random glucose ≥ 200 mg/dL, or two-hour 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, Lasparaginase),
    4. atypical antipsychotics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722397

Contacts
Contact: Kathryn Hirst, PhD 301-881-9260 ext 8025 khirst@bsc.gwu.edu

Locations
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            
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided

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

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
genetics, pediatrics

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009