Depression & Insulin Sensitivity in Adolescents

Not Applicable

Recruiting

• Conditions: Insulin Resistance; Adolescent Obesity; Type 2 Diabetes Mellitus; Insulin Sensitivity; Type2 Diabetes; Depression
• Interventions: Behavioral: Health education group; Behavioral: Cognitive-behavioral therapy group

• Registration Number: NCT03263351
• Lead Sponsor: Colorado State University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-28
• Study Start: 2017-10-01
• Primary Completion: 2024-03-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health education group	Health education group	Six-session health education group program designed as a health education curriculum for teenagers. The program is facilitated by a psychologist. Sessions are weekly for 1-hour.
Cognitive-behavioral therapy group	Cognitive-behavioral therapy group	Six-session cognitive-behavioral therapy group program designed as a prevention of depression intervention for adolescents at-risk for depression. The program is facilitated by a psychologist. Sessions are weekly for 1-hour.

Primary Outcome Measures

Name	Time	Method
Insulin secretion	1-year	Oral disposition index estimated from 2-hour oral glucose tolerance test
Insulin sensitivity	1-year	Whole body insulin sensitivity index estimated from 2-hour oral glucose tolerance test
Depressive symptoms	1-year	Center for Epidemiologic Studies-Depression Scale (CES-D) total score

Secondary Outcome Measures

Name	Time	Method
Physical inactivity	1-year	Sedentary time by accelerometer
Sleep	1-year	Sleep duration by actigraphy
Cortisol diurnal rhythm	1-year	Salivary cortisol by home collection throughout the day
Daily cortisol output	1-year	24-hour urine cortisol
Disinhibited eating	1-year	Emotional Eating Scale adapted for Children depression scale
Physical activity	1-year	Moderate-to-vigorous physical activity by accelerometer

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States