Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Reduction of Adolescent Risk Factors for Type 2 Diabetes and Cardiovascular Disease
Brief Summary: The purpose of this study is to assess the sustainability of a two-year intervention aimed at improving body mass index (BMI) and metabolic and vascular health in obese youth. The study will compare lifestyle changes with diet and exercise alone with changes in lifestyle in combination with metformin medication. An initial intensive exercise program will also be compared with a standard exercise program.

Hypothesis: Metformin therapy in combination with intensive lifestyle intervention in obese children and adolescents will be associated with reduced rate of weight gain, improved BMI, body composition, physical activity, physical fitness, insulin sensitivity, blood lipid profiles, adipocytokines and vascular function.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Metformin | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Metformin, Drug: Rosiglitazone | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: Metformin, Behavioral: Lifestyle Program | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): 1, 2, 3 | Intervention Type: DRUG; Name: Rosiglitazone; Assigned to Arm(s): 2 | Intervention Type: BEHAVIORAL; Name: Lifestyle Program; Assigned to Arm(s): 3
B: Intervention Type: PROCEDURE; Name: Interpersonal Psychotherapy; Assigned to Arm(s): N/A
C: Arm Label: Metformin, Standard exercise; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin and standard exercise | Arm Label: Placebo, Standard exercise; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Placebo Standard exercise | Arm Label: Metformin, Intensive exercise; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin Intensive exercise | Arm Label: Placebo, Intensive exercise; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Intensive exercise | Intervention Type: DRUG; Name: Metformin and standard exercise; Assigned to Arm(s): Metformin, Standard exercise | Intervention Type: DRUG; Name: Metformin Intensive exercise; Assigned to Arm(s): Metformin, Intensive exercise | Intervention Type: BEHAVIORAL; Name: Placebo Standard exercise; Assigned to Arm(s): Placebo, Standard exercise | Intervention Type: BEHAVIORAL; Name: Intensive exercise; Assigned to Arm(s): Placebo, Intensive exercise
D: 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

Answer: C