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Diacerein on Insulin Secretion in Diabetes

This study has been completed.
Sponsor:
Collaborator:
National Council of Science and Technology, Mexico
Information provided by:
Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01298882
First received: January 31, 2011
Last updated: February 16, 2011
Last verified: January 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Overweight
Obesity
 Drug: Diacerein
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Effect of Diacerein on Insulin Secretion in Patients With Type 2 Diabetes Mellitus and Overweight or Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Fasting insulin concentration [ Time Frame: 2 mo ] [ Designated as safety issue: No ]
  • Fasting glucose concentration [ Time Frame: 2 mo ] [ Designated as safety issue: No ]
  • A1C concentration [ Time Frame: 2 mo ] [ Designated as safety issue: No ]
  • First phase of insulin secretion [ Time Frame: 2 mo ] [ Designated as safety issue: No ]
  • Late phase of insulin secretion [ Time Frame: 2 mo ] [ Designated as safety issue: No ]
  • Total insulin secretion concentration [ Time Frame: 2 mo ] [ Designated as safety issue: No ]

Arms Assigned Interventions
Experimental: Diacerein Drug: Diacerein
Placebo Comparator: Placebo Other: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298882

Locations
Mexico
Unidad de Investigación Médica en Epidemiología Clínica
Guadalajara, Jalisco, Mexico, 44380
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
National Council of Science and Technology, Mexico
  More Information

No publications provided by Coordinación de Investigación en Salud, Mexico

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Manuel González-Ortiz, CIS Mexico
ClinicalTrials.gov Identifier: NCT01298882     History of Changes
Other Study ID Numbers: DIADM2-001
Study First Received: January 31, 2011
Last Updated: February 16, 2011
Health Authority: Mexico: Coordinación de Investigación en Salud

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Type 2 diabetes mellitus
Overweight
Obesity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms
Diacetylrhein
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013