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Depression & Insulin Sensitivity in Adolescents

Depression and Insulin Sensitivity in Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03263351
Enrollment
147
Registered
2017-08-28
Start date
2017-10-01
Completion date
2025-05-26
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Obesity, Depression, Insulin Resistance, Insulin Sensitivity, Type2 Diabetes, Type 2 Diabetes Mellitus

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.

Interventions

BEHAVIORALCognitive-behavioral therapy group

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

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

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Children's Hospital Colorado
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Colorado State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Research staff who assess outcomes will be blinded to condition assignment.

Intervention model description

This is a randomized controlled behavioral trial with two conditions - cognitive-behavioral therapy group or health education group - run in parallel.

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depressive symptoms1-yearCenter for Epidemiologic Studies-Depression Scale (CES-D) total score
Insulin sensitivity1-yearWhole body insulin sensitivity index estimated from 2-hour oral glucose tolerance test
Insulin secretion1-yearOral disposition index estimated from 2-hour oral glucose tolerance test

Secondary

MeasureTime frameDescription
Sleep1-yearSleep duration by actigraphy
Disinhibited eating1-yearEmotional Eating Scale adapted for Children depression scale
Daily cortisol output1-year24-hour urine cortisol
Cortisol diurnal rhythm1-yearSalivary cortisol by home collection throughout the day
Physical activity1-yearModerate-to-vigorous physical activity by accelerometer
Physical inactivity1-yearSedentary time by accelerometer

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026