Mood and Insulin Resistance in Adolescents At-Risk for Diabetes

NCT01425905 | Completed Phase 2

• 2 other identifiers: 11023911-CH-0239
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Impaired Glucose Tolerance

Keywords

Female; Depression; Obesity; Insulin Resistance; Adolescents; Overweight; Type 2 Diabetes Risk; Mood

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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.

Study Arms (2)

Depression Prevention

EXPERIMENTAL

Other: The Blues Program

Health Education

ACTIVE COMPARATOR

Other: Hey Durham

Interventions

The Blues Program OTHER

Depression Prevention

Hey Durham OTHER

Health Education

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• National Institutes of Health Clinical Center (CC): collaborator

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (6)

• Moss SE, Klein R, Klein BE. Cause-specific mortality in a population-based study of diabetes. Am J Public Health. 1991 Sep;81(9):1158-62. doi: 10.2105/ajph.81.9.1158.

  PMID: 1951827 BACKGROUND

• Fox CS, Coady S, Sorlie PD, D'Agostino RB Sr, Pencina MJ, Vasan RS, Meigs JB, Levy D, Savage PJ. Increasing cardiovascular disease burden due to diabetes mellitus: the Framingham Heart Study. Circulation. 2007 Mar 27;115(12):1544-50. doi: 10.1161/CIRCULATIONAHA.106.658948. Epub 2007 Mar 12.

  PMID: 17353438 BACKGROUND

• Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010 Jul 10;376(9735):124-36. doi: 10.1016/S0140-6736(09)62124-3. Epub 2010 Jun 26.

  PMID: 20580421 BACKGROUND

• Gulley LD, Shomaker LB, Kelly NR, Chen KY, Olsen CH, Tanofsky-Kraff M, Yanovski JA. Examining cognitive-behavioral therapy change mechanisms for decreasing depression, weight, and insulin resistance in adolescent girls at risk for type 2 diabetes. J Psychosom Res. 2022 Jun;157:110781. doi: 10.1016/j.jpsychores.2022.110781. Epub 2022 Mar 10.

  PMID: 35367918 DERIVED

• Shomaker LB, Kelly NR, Pickworth CK, Cassidy OL, Radin RM, Shank LM, Vannucci A, Thompson KA, Armaiz-Flores SA, Brady SM, Demidowich AP, Galescu OA, Courville AB, Olsen C, Chen KY, Stice E, Tanofsky-Kraff M, Yanovski JA. A Randomized Controlled Trial to Prevent Depression and Ameliorate Insulin Resistance in Adolescent Girls at Risk for Type 2 Diabetes. Ann Behav Med. 2016 Oct;50(5):762-774. doi: 10.1007/s12160-016-9801-0.

  PMID: 27333897 DERIVED

• Radin RM, Tanofsky-Kraff M, Shomaker LB, Kelly NR, Pickworth CK, Shank LM, Altschul AM, Brady SM, Demidowich AP, Yanovski SZ, Hubbard VS, Yanovski JA. Metabolic characteristics of youth with loss of control eating. Eat Behav. 2015 Dec;19:86-9. doi: 10.1016/j.eatbeh.2015.07.002. Epub 2015 Jul 18.

  PMID: 26210388 DERIVED

MeSH Terms

Conditions

Depression; Glucose Intolerance; Obesity; Insulin Resistance; Overweight

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Study Officials

• Jack A Yanovski, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2011
• First Posted: August 30, 2011
• Study Start: August 23, 2011
• Primary Completion: August 10, 2015
• Study Completion: August 10, 2015
• Last Updated: December 16, 2019

Record last verified: 2016-01-27

Locations

US (1)