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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Unidad de Investigación Médica en Epidemiología Clínica
Guadalajara, Jalisco, Mexico
Fasting insulin concentration
Time frame: 2 mo
Fasting glucose concentration
Time frame: 2 mo
A1C concentration
Time frame: 2 mo
First phase of insulin secretion
Time frame: 2 mo
Late phase of insulin secretion
Time frame: 2 mo
Total insulin secretion concentration
Time frame: 2 mo
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