Implication of free radicals produced by xanthine oxidase in mitochondrial alterations of skeletal muscle in diabetic patients - DIAXO

INTERVENTION: Pharmaceutical Form: Capsule* CAS Number: 315‐30‐0 Other descriptive name: ALLOPURINOL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Type 2 diabetes; MedDRA version: 12.1 Level: LLT Classification code 10067585 Term: Type 2 diabetes mellitus PRIMARY OUTCOME: Main Objective: To measure the reduction of oxidative stress in muscle with allopurinol treatment versus placebo in patients with type 2 diabetes. Primary end point(s): Muscle oxidative stress will be estimated by measuring protein carbonylation and the expression of pro- and anti-oxidant genes. Secondary Objective: - To measure the reduction of oxidative stress in blood with allopurinol treatment versus placebo in patients with type 2 diabetes; - To measure the improvement in mitochondrial structure in the muscle of diabetic patients receiving allopurinol versus placebo; - To measure the improvement in mitochondrial function in the muscle of diabetic patients receiving allopurinol versus placebo. - To measure the impact of allopurinol treatment on the amount of intramuscular lipids; - To measure the impact of allopurinol treatment on the insulin sensitivity of diabetic patients; - To evaluate the tolerability of the treatment; INCLUSION CRITERIA: - Male or female - Aged 30 to 60 years - Body mass index between 25 and 40 kg/m² - Type 2 diabetes for more than one year but less than 10 years - HbA1c ≤ 9% - Uric acid > 300 µmol/L - Taking oral antidiabetic medication or a GLP-1 analog - Normal coagulation profile - Negative pregnancy test for women of childbearing age - Use of contraception for women of childbearing age throughout the study - Creatinine clearance > 80 mL/min - Normal Gamma GT, AST and ALT < 3 times the upper limit of normal - Sedentary or moderately active (< 4 hours per week) subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range