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Completed

NCT Number: NCT03263351

Depression & 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.

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Key information

About this study

There has been rapid escalation of type 2 diabetes (T2D) rates in adolescents. Early-onset T2D (<20y) typically shows a more aggressive course than adult-onset T2D and disproportionately affects 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 often manifest in adolescence and are a prospective risk factor for worsening of insulin sensitivity, the major physiological precursor-in combination with deterioration of pancreatic β-cell capacity to secrete insulin-in the path to T2D. The effects of depression on poor insulin sensitivity remain even after accounting for adiposity. In theory, depressive symptoms may worsen insulin sensitivity through stress-induced behaviors (e.g., disinhibited eating, physical inactivity, sleep disturbance) and stress-induced physiological causal mechanisms (e.g., hypercortisolism). The central theme of this study is that intervening to reduce depressive symptoms in adolescents at-risk for T2D may offer an innovative, targeted approach to ameliorate insulin resistance and to, consequently, preserve β-cell function and lessen T2D risk. In preliminary data, the investigators found initial evidence that a 6-week cognitive-behavioral group decreased depressive symptoms and prevented worsening of insulin sensitivity 1 year later in overweight and obese girls with moderate depressive symptoms and a family history of T2D, in comparison to a 6-week health education control group. Directly extending these findings, the primary aims of this study are: 1) to assess the efficacy of a 6-week cognitive-behavioral depression group vs. a 6-week health education control group for improving insulin sensitivity and preserving β-cell function 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 behavioral explanatory mediators underlying the relationship between decreases in depressive symptoms and improvements in insulin sensitivity and β-cell function over 1 year and 3) to test changes in cortisol awakening response, diurnal cortisol rhythm, and total daily cortisol output as physiological mechanisms explaining the relationship between decreases in depressive symptoms and improvements in insulin sensitivity and β-cell function over 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-behavioral therapy group

Behavioral

Psychoeducation on depression; cognitive restructuring of negative thoughts; engagement in pleasant activities; healthy rewards; stress and coping.

Other names: Blues Program

Health Education group

Behavioral

Didactic health knowledge about interpersonal violence; basic nutrition guidance; sun safety; depression and signs of suicide; gang violence; substance use.

Other names: Hey-Durham

Primary outcomes

  1. Depressive symptoms

    Time frame: 1-year

    Center for Epidemiologic Studies-Depression Scale (CES-D) total score

  2. Insulin sensitivity

    Time frame: 1-year

    Whole body insulin sensitivity index estimated from 2-hour oral glucose tolerance test

  3. Insulin secretion

    Time frame: 1-year

    Oral disposition index estimated from 2-hour oral glucose tolerance test

Secondary outcomes

  1. Disinhibited eating

    Time frame: 1-year

    Emotional Eating Scale adapted for Children depression scale

  2. Physical activity

    Time frame: 1-year

    Moderate-to-vigorous physical activity by accelerometer

  3. Physical inactivity

    Time frame: 1-year

    Sedentary time by accelerometer

  4. Sleep

    Time frame: 1-year

    Sleep duration by actigraphy

  5. Cortisol diurnal rhythm

    Time frame: 1-year

    Salivary cortisol by home collection throughout the day

  6. Daily cortisol output

    Time frame: 1-year

    24-hour urine cortisol

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • 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)

Registry information

Official study title

Depression and Insulin Sensitivity in Adolescents

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2017
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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