Overview

Metformin & Inflammation in Pre-diabetic Children

Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
Hypothesis. To determine the effect of metformin on the concentrations of resistin and other insulin resistance or inflammatory markers (C-reactive protein, cytokines, body weight, HbA1c, among others) in minors with glucose intolerance. Children with glucose intolerance are given either metformin or placebo for 12 consecutive weeks. High sensitivity C-reactive protein, TNF-alpha, IL-6, IL1-beta, resistin, leptin, adiponectin, glucose, insulin, HbA1c, lipid profile and transaminases are measured at the beginning and at the end of the period. Statistical analysis: t Student test; Friedman and Kruskal Wallis test are used. Variables are adjusted for: sex, age, baseline BMI and percentage weight change.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Treatments:
Metformin