Metformin & Inflammation in Pre-diabetic Children

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coordinación de Investigación en Salud, Mexico
• Treatments: Metformin

Criteria

Inclusion Criteria:

• pediatric patients with glucose intolerance per ADA criteria,

• free of acute or chronic inflammatory processes 3 months prior to recruitment,

• 4-17 years of age

Exclusion Criteria:

• previous personal history of diabetes or demonstrating diabetes in OGTT curve,

• chronic renal disease or serum creatinine over 1.4 mg/dl (females) or 1.5 (males),

• active hepatic disease,

• smoking,

• primary dislipidemia,

• heart problems,

• steroids,

• chronic metabolic acidosis,

• receiving anti-hypertensive or hypolipemia or hypoglucemia medications