Diacerein on Insulin Secretion in Diabetes

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coordinación de Investigación en Salud, Mexico
• Collaborator: National Council of Science and Technology, Mexico
• Treatments: Diacetylrhein

Criteria

Inclusion Criteria:

• Fasting glucose levels between 7.0 and 11.1 mmol/L

• A1C levels between 7 and 9%

• Same residential area and socioeconomic status

• Excessively sedentary or participated in heavy physical activity

• Nonsmokers

• Body weight was stable for at least 3 months before the study

• Blood pressure was <130/80 mm Hg

Exclusion Criteria:

• Personal history of hepatic, renal or coronary artery disease

• Medications known to affect metabolism during the previous 6 months.