Status:
COMPLETED
TODAY Genetics Study
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- inhaled steroids at dose above 1000 mcg daily fluticasone equivalent,
- oral glucocorticoids,
- antirejection or chemotherapy agents (e.g., tacrolimus, L-asparaginase),
- atypical antipsychotics.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
2654 Patients enrolled
Trial Details
Trial ID
NCT00722397
Start Date
August 1 2008
End Date
February 1 2015
Last Update
August 4 2021
Active Locations (25)
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1
UAMS Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027
3
UCSD Rady Children's Hospital
San Diego, California, United States, 92123
4
University of Colorado Denver
Aurora, Colorado, United States, 80045