Status:
COMPLETED
Mood and Insulin Resistance in Adolescents At-Risk for Diabetes
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health Clinical Center (CC)
Conditions:
Depression
Impaired Glucose Tolerance
Eligibility:
FEMALE
12-17 years
Phase:
PHASE2
Brief Summary
Background: Type 2 diabetes is a chronic disease that puts individuals at risk for serious health problems like heart disease, kidney failure, vision problems, and stroke. A major way that type 2 dia...
Detailed Description
The alarming rise in prevalence of type 2 diabetes (T2D) among adolescents and young adults poses an enormous public health burden. Insulin resistance (IR) is a major physiological precursor to T2D. D...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 12-17 years
- Female
- BMI greater than or equal to 85th percentile for age.
- CES-D greater than or equal to 16
- Good general health
- T2D or prediabetes (impaired fasting glucose greater than or equal to 100 mg/dL or impaired glucose tolerance: 2h glucose tolerance test glucose greater than or equal to 140 mg/dL) family history in a first- or second- degree relative.
- English-speaking
- EXCLUSION CRITERIA:
- Current major depressive episode
- Current psychiatric symptoms requiring treatment
- Fasting glucose \>126 mg/dL
- 2-hour OGTT glucose \>200 mg/dL
- Pregnancy
- Use of medication affecting IR, weight, or mood
- Current psychotherapy or weight loss treatment
Exclusion
Key Trial Info
Start Date :
August 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2015
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT01425905
Start Date
August 23 2011
End Date
August 10 2015
Last Update
December 16 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892