Role of Allopurinol on Oxidative Stress and Mitochondrial Alterations in Skeletal Muscle of Diabetic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-16

Study Completion Date

2016-02-18

Brief Summary

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Our recent data in mice have demonstrated a key role of xanthine oxidase in hyperglycemia-induced by Reactive oxygen species production, and a preventive role of allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and structure, in skeletal muscle of diabetic mice. The investigators want to initiate a clinical trial in order to evaluate the efficacy of allopurinol on the improvement of mitochondrial alterations, oxidative capacities and insulin sensitivity, in skeletal muscle of type 2 diabetic patients.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Allopurinol

Allopurinol, experimental arms, type 2 diabetes subjects receive 2 capsules of allopurinol 150 mg daily for 3 month

Group Type EXPERIMENTAL

2 capsules of allopurinol 150 mg daily for 3 month

Intervention Type DRUG

2 capsules of allopurinol 150 mg daily for 3 month

Placebo

Placebo, type 2 diabetes subjects receive 2 capsules of lactose (placebo) daily for 3 month

Group Type PLACEBO_COMPARATOR

2 capsules of lactose daily for 3 month

Intervention Type DRUG

2 capsules of lactose daily for 3 month

Interventions

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2 capsules of allopurinol 150 mg daily for 3 month

Intervention Type DRUG

2 capsules of lactose daily for 3 month

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* BMI from 25 to 40 kg/m²
* Type 2 diabetes known for over one year but less than 10 years, treated with Oral anti-diabetic drugs or a Glucagon-like peptide-1 (GLP1-analog)
* well controlled hypertension (untreated or currently treated) with a systolic blood pressure of 95 to 140 mmHg and diastolic blood pressure of 45 to 90 mmHg and heart frequency of 40 to 100 per minute
* Recent HbA1c \< 9 %
* Uricemia \> 300 µmol/l
* For women : Menopausal or contraception
* Renal function as defined by glomerular filtration rate (GFR) ≥ 80 mL/min/1.73 m2

Exclusion Criteria

* Tobacco ( more than 5 cigarettes)
* Excessive drinking
* Known pathology
* Hypersensitivity to allopurinol
* Treatment by anticoagulants, allopurinol, regular steroids or Nonsteroidal anti-inflammatory drug (NSAID), fibrate or insulin

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No