Effect of Allopurinol on Mono and Co-administration With Statins on Platelets Reactivity on Diabetic Patiets Treated With Aspirin and Insulin

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus Type 2 Platelets Reactivity Statin

Treatments: Drug: Atorvastatin 80mg; Drug: ALLOPURINOL 300 MG; Drug: Atorvastatin 80mg AND allopurinol 300 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03195153

UNIVERSITY OF ROME

Details and patient eligibility

About

Diabetes mellitus is associated with an increased risk of cardiovascular disease. Substantial clinical and experimental evidence suggest that both diabetes and insulin resistance cause a combination of endothelial dysfunctions, which may diminish the anti-atherogenic role of the vascular endothelium. Therefore, in patients with diabetes or insulin resistance, endothelial dysfunction may be a critical early target for preventing atherosclerosis and cardiovascular disease. It has been implicated as an independent risk factor for cardiovascular disease and premature cardiovascular mortality for patients with type 1 and type 2 diabetes mellitus, as well as for patients with essential hypertension. A complete biochemical understanding of the mechanisms by which hyperglycemia causes vascular functional and structural changes associated with the diabetic milieu still eludes us. In recent years, the numerous biochemical and metabolic pathways postulated to have a causal role in the pathogenesis of diabetic vascular disease have been distilled into several unifying hypotheses. The role of chronic hyperglycemia in the development of diabetic microvascular complications and in neuropathy has been clearly established. However, the biochemical or cellular links between elevated blood glucose levels, and the vascular lesions remain incompletely understood. A number of trials have demonstrated that statins therapy as well as angiotensin converting enzyme inhibitors is associated with improvements in endothelial function in diabetes. Although antioxidants provide short-term improvement of endothelial function in humans, all studies of the effectiveness of preventive antioxidant therapy have been disappointing. Actually, control of hyperglycemia thus remains the best way to improve endothelial function and to prevent atherosclerosis and other cardiovascular complications of diabetes.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• diabetic patient;
• therapy with aspirin and insulin;
• patient well responders

Exclusion criteria

• not diabetic patient;
• patients in dual antiplatelet therapy;
• patient with severe renal failure;
• patient poor responders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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200 participants in 3 patient groups

statin only

Experimental group

Description:

30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)

Treatment:

Drug: Atorvastatin 80mg

allopurinol only

Experimental group

Description:

30 DAYS OF ALLOPURINOL (300 MG)

Treatment:

Drug: ALLOPURINOL 300 MG

statin and allopurinol

Experimental group

Description:

30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL

Treatment:

Drug: Atorvastatin 80mg AND allopurinol 300 mg