Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Mood and Insulin Resistance in Adolescents At-Risk for Diabetes
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.


Options:
A: Arm Label: Diet/Exercise only, then Diet/Exercise plus Metformin; Type: EXPERIMENTAL; Interventions: Drug: Metformin, Behavioral: Dietary modification with caloric restriction, Behavioral: Establishment of exercise protocol | Arm Label: Diet/Exercise plus Metformin, then Diet/Exercise only; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin, Behavioral: Dietary modification with caloric restriction, Behavioral: Establishment of exercise protocol | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Diet/Exercise only, then Diet/Exercise plus Metformin, Diet/Exercise plus Metformin, then Diet/Exercise only | Intervention Type: BEHAVIORAL; Name: Dietary modification with caloric restriction; Assigned to Arm(s): Diet/Exercise only, then Diet/Exercise plus Metformin, Diet/Exercise plus Metformin, then Diet/Exercise only | Intervention Type: BEHAVIORAL; Name: Establishment of exercise protocol; Assigned to Arm(s): Diet/Exercise only, then Diet/Exercise plus Metformin, Diet/Exercise plus Metformin, then Diet/Exercise only
B: Arm Label: Depression Prevention; Type: EXPERIMENTAL; Interventions: Other: The Blues Program | Arm Label: Health Education; Type: ACTIVE_COMPARATOR; Interventions: Other: Hey Durham | Intervention Type: OTHER; Name: The Blues Program; Assigned to Arm(s): Depression Prevention | Intervention Type: OTHER; Name: Hey Durham; Assigned to Arm(s): Health Education
C: Intervention Type: DRUG; Name: glucophage XR; Assigned to Arm(s): N/A
D: Arm Label: Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin, Behavioral: Lifestyle intervention | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Lifestyle intervention | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin | Intervention Type: BEHAVIORAL; Name: Lifestyle intervention; Assigned to Arm(s): Metformin, Placebo

Answer: B