Effect of Metformin and Rosiglitazone Over no Diabetic With Metabolic Syndrome Patients.
Condition: Insulin Resistance
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose
      homeostasis (GH) in no diabetic metabolic syndrome individuals. A randomized blinded clinical
      trial did in patients with metabolic syndrome (n=30), without diabetes. Prior to detailed
      information and signature of informed consent by patients were done three treatment groups by
      randomized technique; a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day),
      treatment was administered for 8 weeks. GH was measured before and after treatment using oral
      glucose tolerance test (OGTT), and IR-index (Homeostatic Model). Determination was performed
      on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels,
      triglycerides, HDL-cholesterol and insulin.
    

Detailed description: 
      Metabolic syndrome is a risk factor for diabetes mellitus characterized by insulin
      resistance, hypertension, triglyceride elevation, low levels of high-density lipoproteins,
      and obesity. Metformin and rosiglitazone are two insulinosensensitizers used in the treatment
      of diabetes. Now there is controversy over the use of insulinossensitizers in non-diabetic
      patients with metabolic syndrome. To compare the effect of insulin sensitizing drugs
      (metformin and rosiglitazone) over glucose homeostasis (GH) in no diabetic metabolic syndrome
      individuals. Randomized blinded clinical trial in patients with metabolic syndrome without
      diabetes was done, sample size (n=30). Prior to detailed information and signature of
      informed consent by patients was randomized forming three treatment groups, a) Placebo, b)
      Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks.
      GH was measured before and after treatment using oral glucose tolerance test (OGTT), and
      IR-index (Homeostatic Model). Determination was performed on weight, size, body mass index,
      plicometry, blood pressure, fasting glucose levels, triglycerides, HDL-cholesterol and
      insulin. Statistic no parametric (Kruskal Wallis, Wilcoxon, U Mann Whitney) to compare
      characteristics inter o intra groups was done. Exact Fisher test was used for qualitative
      variable, and consider significance with p<0.05.
    

Intervention name(s): Metformin group; Rosiglitazone group; Placebo oral tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): We add treatment with Metformin (850 mg/day), treatment was administered for 8 weeks; we add Rosiglitazone (4 mg/day), treatment was administered for 8 weeks; We add Placebo, treatment was administered for 8 weeks
Other intervention name(s): Metformina; Rosiglitazona; Control Group
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prior to detailed information and signature of informed consent by patients, it was randomized forming three treatment groups, a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment