CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Metformin group +2 moredrug
Likely dose
Metformin group 850 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04148183
NCT04148183Phase 3Completed

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

J JESUS VENEGAS, MD·interventional·Posted Nov 1, 2019·Updated Nov 5, 2019

In Brief

A Phase 3 clinical trial evaluating Metformin group, Rosiglitazone group, and 1 other intervention for Insulin Resistance. Completed, enrolled 30 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 1, 2019
Enrollment StartJan 1, 2004
Primary CompletionJan 1, 2005
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 6.7 years ago

Interventions

Metformin groupdrug

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

Rosiglitazone groupdrug

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

Placebo oral tabletdrug

We add Placebo, treatment was administered for 8 weeks