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TODAY Genetics Study

This study is not yet open for participant recruitment.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), July 2008

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:   November 2008 (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    
      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

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


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

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
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 24, 2008




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