Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adolescent Obesity
  • Depression
  • Insulin Resistance
  • Insulin Sensitivity
  • Type 2 Diabetes Mellitus
  • Type2 Diabetes
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This is a randomized controlled behavioral trial with two conditions - cognitive-behavioral therapy group or health education group - run in parallel.Masking: Single (Outcomes Assessor)Masking Description: Research staff who assess outcomes will be blinded to condition assignment.Primary Purpose: Prevention

Participation Requirements

Age
Between 12 years and 17 years
Gender
Only males

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 depres...

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 ?-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 ?-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 ?-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 ?-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 ?-cell function over 1 year.

Tracking Information

NCT #
NCT03263351
Collaborators
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Advancing Translational Science (NCATS)
  • Children's Hospital Colorado
Investigators
Not Provided