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Completed

NCT Number: NCT01298882

Diacerein on Insulin Secretion in Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Unidad de Investigación Médica en Epidemiología Clínica

Guadalajara, Jalisco, 44380, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diacerein

Drug

Placebo

Other

Primary outcomes

  1. Fasting insulin concentration

    Time frame: 2 mo

  2. Fasting glucose concentration

    Time frame: 2 mo

  3. A1C concentration

    Time frame: 2 mo

  4. First phase of insulin secretion

    Time frame: 2 mo

  5. Late phase of insulin secretion

    Time frame: 2 mo

  6. Total insulin secretion concentration

    Time frame: 2 mo

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • National Council of Science and Technology, Mexico

Registry information

Official study title

Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity

Important dates

First posted
Feb 18, 2011
Registry last updated
Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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