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

NCT04148183 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-11-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Metformin group

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

DRUG

Rosiglitazone group

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

DRUG

Placebo oral tablet

We add Placebo, treatment was administered for 8 weeks

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    collaborator OTHER_GOV

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • J JESUS VENEGAS, MD

    lead OTHER

Principal Investigators

  • Carlos Tene, DS · Universidad de Colima

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-01
Primary Completion
2005-01-01
Completion
2009-01-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04148183 on ClinicalTrials.gov