Status:
COMPLETED
Depression & Insulin Sensitivity in Adolescents
Lead Sponsor:
Colorado State University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Type2 Diabetes
Type 2 Diabetes Mellitus
Eligibility:
FEMALE
12-17 years
Phase:
NA
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,...
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 girl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2025
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT03263351
Start Date
October 1 2017
End Date
May 26 2025
Last Update
September 23 2025
Active Locations (1)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045