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

J JESUS VENEGAS, MD

Status and phase: Completed; Phase 3; Phase 2

Conditions: Insulin Resistance

Treatments: Drug: Placebo oral tablet; Drug: Rosiglitazone group; Drug: Metformin group

Study type: Interventional

Funder types: Other

Identifiers

NCT04148183

Ucol-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Metformin Group

Experimental group

Description:

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

Treatment:

Drug: Metformin group

Rosiglitazone Group

Experimental group

Description:

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

Treatment:

Drug: Rosiglitazone group

Placebo Group

Placebo Comparator group

Description:

Placebo treatment was administered for 8 weeks

Treatment:

Drug: Placebo oral tablet