Mood and Insulin Resistance in Adolescents At-Risk for Diabetes
Condition: Depression; Impaired Glucose Tolerance
MeSH terms: Insulin Resistance; Glucose Intolerance; Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

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.
    

Intervention name(s): The Blues Program; Hey Durham
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Female; Depression; Obesity; Insulin Resistance; Adolescents; Overweight; Type 2 Diabetes Risk; Mood