drugset / Trial / NCT01394887
Metformin & Inflammation in Pre-diabetic Children
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2002-07
- Primary completion
- 2003-07
- Completion
- 2011-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | 850 mg | Oral |