Effect of Metformin and Rosiglitazone Over no Diabetic With Metabolic Syndrome Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial, Effect of Metformin and Rosiglitazone Over Glucose Homeoastasis in no Diabetic With Metabolic Syndrome Patients.

Conditions
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Insulin Resistance

Intervention / Treatment
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* Drug: Metformin group
* Drug: Rosiglitazone group
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years old. Metabolic Syndrome criteria of World Health Organization . Exclusion Criteria: Diabetes Mellitus Allergic to Metformin, Allergic to rosiglitazone. Hepatic disease. Hearth disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin Group<br>Metformin (850 mg/day) treatment was administered for 8 weeks | Drug: Metformin group<br>* We add treatment with Metformin (850 mg/day), treatment was administered for 8 weeks<br>* Other names: Metformina;|
| Experimental: Rosiglitazone Group<br>Rosiglitazone (4 mg/day), treatment was administered for 8 weeks | Drug: Rosiglitazone group<br>* we add Rosiglitazone (4 mg/day), treatment was administered for 8 weeks<br>* Other names: Rosiglitazona;|
| Placebo Comparator: Placebo Group<br>Placebo treatment was administered for 8 weeks | Drug: Placebo oral tablet<br>* We add Placebo, treatment was administered for 8 weeks<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INSULIN RESISTANCE | INSULIN RESISTANCE index (Homeostatic Model) is method that need insulin concentration and glucose in blood to calculate index. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral glucose tolerance test (OGTT), | oral glucose tolerance test was done take a sample of blood before a period without feed of 8 hours, we took a blood glucose sample then we gave a 75g of glucose and after we took blood glucose at the hour and 2 hours of OGTT test | 8 weeks |