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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus Type 2 Platelets Reactivity Statin
• Intervention / Treatment: Drug: Atorvastatin 80mg; Drug: ALLOPURINOL 300 MG; Drug: Atorvastatin 80mg AND allopurinol 300 mg

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Roma
    • Rome, Roma, Italy, 00155
      • Recruiting
      • Policlinico Umberto I
      • Contact: MARINA MD POLACCO; Phone Number: 3333347960; Email: POLAMARI@LIBERO.IT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: statin only; 30 DAYS OF STATIN THERAPY ATORVASTATIN 80 MG)	Drug: Atorvastatin 80mg; 30 DAYS OF atorvastatin 80 mg
Experimental: allopurinol only; 30 DAYS OF ALLOPURINOL (300 MG)	Drug: ALLOPURINOL 300 MG; 30 DAYS OF ALLOPURINOL 300 MG
Experimental: statin and allopurinol; 30 DAYS OF CO-ADMINISTRATION OF ATORVASTATIN AND ALLOPURINOL	Drug: Atorvastatin 80mg AND allopurinol 300 mg; 30 days of atorvastatin and allopurinol 300 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of platelet reaction units Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California] After 30 days of treatment with each drug	Absolute changes in platelet reactivity (expressed as P2Y(12) reaction units by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]	fter 30 days of treatment with each drug

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2017
• Primary Completion (Anticipated): June 23, 2017
• Study Completion (Anticipated): July 15, 2017

Study Registration Dates

• First Submitted: May 28, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 22, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Antioxidants; Free Radical Scavengers; Gout Suppressants; Atorvastatin; Allopurinol
• Other Study ID Numbers: UNIVERSITY OF ROME

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No