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

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: 2 capsules of lactose daily for 3 month; Drug: 2 capsules of allopurinol 150 mg daily for 3 month

Study type: Interventional

Funder types: Other

Identifiers

NCT02533648

2010.639

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Allopurinol

Experimental group

Description:

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

Treatment:

Drug: 2 capsules of allopurinol 150 mg daily for 3 month

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: 2 capsules of lactose daily for 3 month