NCT03263351Completed
Depression & Insulin Sensitivity in Adolescents
Depression and Insulin Sensitivity in Adolescents
Source: ClinicalTrials.gov · Last updated 23 Sept 2025
Brief summary (registry, in English)
There has been a rise in type 2 diabetes (T2D) rates in adolescents, disproportionately in girls from disadvantaged racial/ethnic groups. This group of girls also is at heightened risk for depression, and depression and T2D are linked. Depressive symptoms are a risk factor for worsening of insulin sensitivity, one if the major precursors to T2D. In preliminary studies, the investigators found that a brief cognitive-behavioral therapy group decreased depressive symptoms and prevented worsening of insulin sensitivity in adolescent girls at-risk for T2D with moderate depressive symptoms. The aims of this study are: 1) to assess the efficacy of a cognitive-behavioral therapy depression group vs. a health education control group for improving insulin sensitivity and preserving insulin secretion in racially/ethnically diverse adolescent girls at-risk for T2D with moderate depressive symptoms over a 1-year follow-up; 2) to evaluate changes in eating, physical activity, and sleep as explanatory and 3) to test changes in cortisol factors as explanatory.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 147 (actual)
- First submitted
- 24 Aug 2017
- Start date
- 1 Oct 2017
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Colorado State University
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT03263351
What you commit to
- Study type: Interventional
- Participants enrolled: 147
- From 1 Oct 2017 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medication affecting mood, weight, cortisol, or insulin sensitivity, including insulin sensitizers (e.g., metformin), anti-depressants, and stimulants
Other illness
- Major psychiatric disorder that, in the opinion of the investigators, would impede study compliance and necessitate more intensive treatment, including major depressive disorder, bipolar disorder, posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, schizophrenia, conduct disorder, alcohol and substance abuse, and anorexia/bulimia nervosa
Lab values
- Type 2 diabetes as indicated by fasting glucose≥126 mg/dL or 2-hour glucose\>200 mg/dL or Hba1c\>=6.5
Other
- Pregnancy or breastfeeding
- Psychotherapy or structured weight loss program
- Active suicidal ideation or suicidal behavior
Who the study is looking for
- Female
- Age 12-17 years
- Body mass index (BMI) ≥85th percentile for age \& sex
- Center for Epidemiologic Studies-Depression Scale (CES-D) \>20
- English speaking
- ≥1 first- or second-degree family member with type 2 diabetes (T2D), prediabetes, or gestational diabetes
- Good general health
Age in the registry: 12 years to 17 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.