Trial | NCT04148183  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
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.
Study Started
Jan 01
2004
Primary Completion
Jan 01
2005
Study Completion
Jan 01
2009
Last Update
Nov 05
2019

Drug Metformin group

We add treatment with Metformin (850 mg/day), treatment was administered for 8 weeks

  • Other names: Metformina

Drug Rosiglitazone group

we add Rosiglitazone (4 mg/day), treatment was administered for 8 weeks

  • Other names: Rosiglitazona

Drug Placebo oral tablet

We add Placebo, treatment was administered for 8 weeks

  • Other names: Control Group

Metformin Group Experimental

Metformin (850 mg/day) treatment was administered for 8 weeks

Rosiglitazone Group Experimental

Rosiglitazone (4 mg/day), treatment was administered for 8 weeks

Placebo Group Placebo Comparator

Placebo treatment was administered for 8 weeks

Criteria 

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.
No Results Posted