Depression Clinical Trial
Official title:
Depression and Insulin Sensitivity in Adolescents
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 | Recruiting |
Enrollment | 200 |
Est. completion date | June 30, 2025 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 12 Years to 17 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Pregnancy or breastfeeding - Type 2 diabetes as indicated by fasting glucose=126 mg/dL or 2-hour glucose>200 mg/dL or Hba1c>=6.5 - Medication affecting mood, weight, cortisol, or insulin sensitivity, including insulin sensitizers (e.g., metformin), anti-depressants, and stimulants - 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 - Psychotherapy or structured weight loss program - Active suicidal ideation or suicidal behavior |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado State University | Children's Hospital Colorado, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Advancing Translational Sciences (NCATS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Andrews SA, Colvin HJ. Verification of Intoximeter 3000 breath alcohol concentration by magnesium perchlorate tube method in long-term field program. J Anal Toxicol. 1989 Mar-Apr;13(2):113-6. doi: 10.1093/jat/13.2.113. — View Citation
Shomaker LB, Kelly NR, Radin RM, Cassidy OL, Shank LM, Brady SM, Demidowich AP, Olsen CH, Chen KY, Stice E, Tanofsky-Kraff M, Yanovski JA. Prevention of insulin resistance in adolescents at risk for type 2 diabetes with depressive symptoms: 1-year follow-up of a randomized trial. Depress Anxiety. 2017 Oct;34(10):866-876. doi: 10.1002/da.22617. Epub 2017 Mar 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depressive symptoms | Center for Epidemiologic Studies-Depression Scale (CES-D) total score | 1-year | |
Primary | Insulin sensitivity | Whole body insulin sensitivity index estimated from 2-hour oral glucose tolerance test | 1-year | |
Primary | Insulin secretion | Oral disposition index estimated from 2-hour oral glucose tolerance test | 1-year | |
Secondary | Disinhibited eating | Emotional Eating Scale adapted for Children depression scale | 1-year | |
Secondary | Physical activity | Moderate-to-vigorous physical activity by accelerometer | 1-year | |
Secondary | Physical inactivity | Sedentary time by accelerometer | 1-year | |
Secondary | Sleep | Sleep duration by actigraphy | 1-year | |
Secondary | Cortisol diurnal rhythm | Salivary cortisol by home collection throughout the day | 1-year | |
Secondary | Daily cortisol output | 24-hour urine cortisol | 1-year |
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