Mood and Insulin Resistance in Adolescents At-Risk for Diabetes

December 13, 2019 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Background:

Type 2 diabetes is a chronic disease that puts individuals at risk for serious health problems like heart disease, kidney failure, vision problems, and stroke. A major way that type 2 diabetes occurs is through insulin resistance. Insulin resistance means that insulin (an important hormone in the body to keep blood sugar normal) isn t working as well as it should, which can lead to problems with high blood sugar. Insulin resistance has been linked to mood problems, stress, and depression, especially in women. To determine if group programs can help reduce the risk for type 2 diabetes, researchers want to look at teenage girls who are at risk for developing the disease.

Objectives:

To test whether a group program designed to improve mood also can help improve insulin resistance in teenage girls who are at risk for developing type 2 diabetes, or whether a group program that teaches healthy living skills is just as helpful.

Eligibility:

Teenage girls between 12 and 17 years of age who are at risk for developing type 2 diabetes.

Design:

  • Participants will have two screening visits to find out if they are eligible to take part in the study. The first visit takes about 3 hours and will involve a physical exam, medical history, questionnaires and an interview about mood problems and possible depression. The second visit takes about 6 hours and will involve a full body scan to measure muscle and fat, blood draws and a glucose test to determine insulin resistance, questionnaires about general well-being and eating habits, eating meals and snacks, and an exercise test.
  • Participants will join one of two group programs at the National Institutes of Health. One group focuses on learning skills to help with bad moods and stress. The other group covers topics that are important for teens to lead a healthy life. The groups will meet for 1 hour once a week for 6 weeks during after-school hours.
  • At the end of the groups, participants will have three follow-up visits. The first visit will be 6 weeks later, the second will be 6 months after the start of the group program, and the third will be 1 year after the start of the group program. Each visit will take about 6 hours. These visits are similar to the second screening visit before the groups.
  • Some participants will have extra tests to study stress at the second screening visit and the 6-week, 6-month, and 12-month follow-up visits. Participants will give samples of DNA, saliva to measure stress hormones, and they will take part in a brief stress test.

For more information, visit the study website at: http://mir.nichd.nih.gov or contact the research coordinators for the study at 301-594-3198.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The alarming rise in prevalence of type 2 diabetes (T2D) among adolescents and young adults poses an enormous public health burden. Insulin resistance (IR) is a major physiological precursor to T2D. Depressive symptoms are associated with IR in adolescents and adults, predict adult-onset T2D, and contribute to increased risk for T2D mortality and morbidity. Depressive symptoms theoretically induce IR by promoting stress-induced behaviors (altered eating, lowered fitness) and upregulating physiological stress mechanisms (cortisol, NPY).

Psychotherapy for depression improves IR in adults, but it is unknown if ameliorating depressive symptoms prevents progression of IR in adolescents at risk for T2D. The aims of this protocol are: 1) to assess the effects of a 6-week cognitive-behavioral (CB) depression prevention group (the Blues Program) vs. a 6-week standard-of-care health education (HE) group on reducing depressive symptoms and improving IR in adolescent girls at risk for T2D; 2) to assess the stress-related behavioral and physiological factors that mediate the relationship underlying decreases in depressive symptoms and improvements in IR; and 3) to test if genotypic variation in NPY is related to severity of depressive symptoms and IR and moderates the efficacy of the CB intervention. The proposed study will permit a rigorous test of the degree to which depressive symptoms contribute to IR. The Blues Program is brief, easy-to-administer, cost-effective, and efficacious for reducing depressive symptoms among adolescent girls. If the Blues Program also improves IR, it would have the potential to have a major impact on T2D prevention in a considerable subset of youth.

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

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

Genders Eligible for Study

Female

Description

  • INCLUSION CRITERIA:
  • Age 12-17 years
  • Female
  • BMI greater than or equal to 85th percentile for age.
  • CES-D greater than or equal to 16
  • Good general health
  • T2D or prediabetes (impaired fasting glucose greater than or equal to 100 mg/dL or impaired glucose tolerance: 2h glucose tolerance test glucose greater than or equal to 140 mg/dL) family history in a first- or second- degree relative.
  • English-speaking

EXCLUSION CRITERIA:

  • Current major depressive episode
  • Current psychiatric symptoms requiring treatment
  • Fasting glucose >126 mg/dL
  • 2-hour OGTT glucose >200 mg/dL
  • Pregnancy
  • Use of medication affecting IR, weight, or mood
  • Current psychotherapy or weight loss treatment

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Health Education
Other: Hey Durham
Experimental: Depression Prevention
Other: The Blues Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Insulin Resistance at 12 months in CB depression prevention versus HE control group.

Secondary Outcome Measures

Outcome Measure
Depressive symptoms at 12 months in CB depression prevention versus HE control group.
CB, depression, prevention, group, will, show, greater, improvements, in, mediators, (eating, behavior, fitness, and stress biomarkers) than the HE control group.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborators

National Institutes of Health Clinical Center (CC)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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

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

August 23, 2011

Primary Completion (Actual)

August 10, 2015

Study Completion (Actual)

August 10, 2015

Study Registration Dates

First Submitted

August 27, 2011

First Submitted That Met QC Criteria

August 27, 2011

First Posted (Estimate)

August 30, 2011

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

January 27, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110239
  • 11-CH-0239

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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