Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Understanding the Effects of Therapeutic Intervention on Cardiovascular Risk Markers, Insulin Resistance, and Intra-Hepatic Fat Contents in Obese Children at High Risk for the Metabolic Syndrome.
Brief Summary: In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise) or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will cross over the treatment arms, i.e., those that were doing diet/exercise intervention only will add metformin, those that were doing the diet/exercise plus metformin will discontinue the metformin and continue with diet/exercise changes only. Intrahepatic fat contents will be measured as well.

The investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome.

The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.


Options:
A: Arm Label: Glucosanol; Type: ACTIVE_COMPARATOR; Interventions: Device: Glucosanol | Intervention Type: DEVICE; Name: Glucosanol; Assigned to Arm(s): Glucosanol
B: 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
C: Arm Label: Sibutramine; Type: EXPERIMENTAL; Interventions: Drug: Sibutramine hydrochloride | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Lead-in sibutramine; Type: EXPERIMENTAL; Interventions: Drug: Sibutramine hydrochloride | Intervention Type: DRUG; Name: Sibutramine hydrochloride; Assigned to Arm(s): Sibutramine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Sibutramine hydrochloride; Assigned to Arm(s): Lead-in sibutramine
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: D