Obesity Clinical Trial
Official title:
Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity
Aim. To assess the effect of interleukin 1β (IL-1β) and tumor necrosis factor α (TNFα)
inhibition with diacerein administration on insulin secretion and metabolic control of
drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.
Hypothesis. Diacerein administration improves insulin secretion and metabolic control of
drug-naïve patients with type 2 diabetes mellitus (T2DM) and overweight or obesity.
Materials and methods. Design: Randomized, double-blind, placebo-controlled clinical trial.
Population: 40 drug-naïve adult patients with T2DM and overweight or obesity. Measurements:
A metabolic profile including IL-1β, TNFα, interleukin 6, and fasting insulin levels, as
well as, hyperglycemic-hyperinsulinemic clamp technique; to assess the phases of insulin
secretion and insulin sensitivity. Intervention for 2 mo: diacerein (50 mg once daily) for
the first 15 days and twice daily for 45 additional days or placebo. Statistical analyses:
Wilcoxon signed rank and Mann-Whitney U test.
n/a
Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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