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

NCT ID: NCT03195153

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2017-07-15

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2 Platelets Reactivity Statin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

statin only

30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)

Group Type: EXPERIMENTAL

Atorvastatin 80mg

Intervention Type: DRUG

30 DAYS OF atorvastatin 80 mg

allopurinol only

30 DAYS OF ALLOPURINOL (300 MG)

Group Type: EXPERIMENTAL

ALLOPURINOL 300 MG

Intervention Type: DRUG

30 DAYS OF ALLOPURINOL 300 MG

statin and allopurinol

30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL

Group Type: EXPERIMENTAL

Atorvastatin 80mg AND allopurinol 300 mg

Intervention Type: DRUG

30 days of atorvastatin and allopurinol 300 mg

Interventions

Atorvastatin 80mg

30 DAYS OF atorvastatin 80 mg

Intervention Type: DRUG

ALLOPURINOL 300 MG

30 DAYS OF ALLOPURINOL 300 MG

Intervention Type: DRUG

Atorvastatin 80mg AND allopurinol 300 mg

30 days of atorvastatin and allopurinol 300 mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Polacco Marina

MD, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico Umberto I

Rome, Roma, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

marina mp polacco

Role: CONTACT

polamari@libero.it

3333347960

Facility Contacts

MARINA MD POLACCO

Role: primary

POLAMARI@LIBERO.IT

3333347960

Other Identifiers

UNIVERSITY OF ROME

Identifier Type: -

Identifier Source: org_study_id