TODAY Genetics Study

This study is currently recruiting participants.
Verified July 2013 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00722397
First received: July 23, 2008
Last updated: July 29, 2013
Last verified: July 2013

July 23, 2008
July 29, 2013
August 2008
February 2014   (final data collection date for primary outcome measure)
Blood draw to be processed and analyzed to yield genetic data. [ Time Frame: Blood is drawn at the single study visit. ] [ Designated as safety issue: No ]
Blood is sent to the DNA processing center identified by NIDDK for processing and shipment to the NIDDK Repository.
Not Provided
Complete list of historical versions of study NCT00722397 on ClinicalTrials.gov Archive Site
  • Phenotype data. [ Time Frame: Collected at single study visit. ] [ Designated as safety issue: No ]
    Demographic, medical history, and other data about participant and family, by self-report.
  • Laboratory values. [ Time Frame: Single study visit. ] [ Designated as safety issue: No ]
    Serum glucose, C-peptide, and pancreatic autoimmunity antibodies determined by study central laboratory.
Not Provided
Not Provided
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TODAY Genetics Study
Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Genetics Study

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
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.

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.

Type 2 Diabetes
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Kathryn Hirst, PhD 301-881-9260 ext 8025 khirst@bsc.gwu.edu
United States
 
NCT00722397
IND - DK61230-GENETICS, DK61230
Yes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Phil Zeitler, MD PhD University of Colorado, Denver
Principal Investigator: Kathryn Hirst, PhD George Washington University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP