- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03263351
Depression & Insulin Sensitivity in Adolescents
December 6, 2023 updated by: Colorado State University
Depression and 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lauren B Shomaker, PhD
- Phone Number: (970)491-3217
- Email: lauren.shomaker@colostate.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Lauren Shomaker, PhD
- Phone Number: 720-777-3138
- Email: lauren.shomaker@childrenscolorado.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Psychoeducation on depression; cognitive restructuring of negative thoughts; engagement in pleasant activities; healthy rewards; stress and coping.
Other Names:
|
Active Comparator: 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.
|
Didactic health knowledge about interpersonal violence; basic nutrition guidance; sun safety; depression and signs of suicide; gang violence; substance use.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive symptoms
Time Frame: 1-year
|
Center for Epidemiologic Studies-Depression Scale (CES-D) total score
|
1-year
|
Insulin sensitivity
Time Frame: 1-year
|
Whole body insulin sensitivity index estimated from 2-hour oral glucose tolerance test
|
1-year
|
Insulin secretion
Time Frame: 1-year
|
Oral disposition index estimated from 2-hour oral glucose tolerance test
|
1-year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disinhibited eating
Time Frame: 1-year
|
Emotional Eating Scale adapted for Children depression scale
|
1-year
|
Physical activity
Time Frame: 1-year
|
Moderate-to-vigorous physical activity by accelerometer
|
1-year
|
Physical inactivity
Time Frame: 1-year
|
Sedentary time by accelerometer
|
1-year
|
Sleep
Time Frame: 1-year
|
Sleep duration by actigraphy
|
1-year
|
Cortisol diurnal rhythm
Time Frame: 1-year
|
Salivary cortisol by home collection throughout the day
|
1-year
|
Daily cortisol output
Time Frame: 1-year
|
24-hour urine cortisol
|
1-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Andrews SA, Colvin HJ. Verification of Intoximeter 3000 breath alcohol concentration by magnesium perchlorate tube method in long-term field program. J Anal Toxicol. 1989 Mar-Apr;13(2):113-6. doi: 10.1093/jat/13.2.113.
- Shomaker LB, Kelly NR, Radin RM, Cassidy OL, Shank LM, Brady SM, Demidowich AP, Olsen CH, Chen KY, Stice E, Tanofsky-Kraff M, Yanovski JA. Prevention of insulin resistance in adolescents at risk for type 2 diabetes with depressive symptoms: 1-year follow-up of a randomized trial. Depress Anxiety. 2017 Oct;34(10):866-876. doi: 10.1002/da.22617. Epub 2017 Mar 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Estimated)
March 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
August 24, 2017
First Submitted That Met QC Criteria
August 25, 2017
First Posted (Actual)
August 28, 2017
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Glucose Metabolism Disorders
- Metabolic Diseases
- Mood Disorders
- Immune System Diseases
- Endocrine System Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Hyperinsulinism
- Obesity
- Depression
- Depressive Disorder
- Hypersensitivity
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Pediatric Obesity
- Insulin Resistance
Other Study ID Numbers
- 4185
- R01DK111604 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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