Type 2 Diabetic Patients Maintained on Statin Therapy

• Status: Completed
• Trial end date: 2020-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Patients with diabetes mellitus (DM) are at increased risk of atherosclerotic cardiovascular disease (ACVD). The achievement of the LDL-C target with statins for the reduction of ACVD risk is recommended. However, the risk is still present. Therefore, we investigated the impact of high sensitivity C-reactive protein (hsCRP), sortilin, adiponectin and leptin biomarkers that linking inflammatory hypothesis of diabetes mellitus and atherosclerosis in diabetic patients treated with rosuvastatin and atrovastatin. Methods: Based on exclusion criteria, 150 type 2 diabetic patients were eligible and randomly assigned to receive either 40 mg per day atorvastatin (ATROVA group, n= 80) or 10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damanhour University
• Collaborator: Tanta University
• Treatments: Atorvastatin; Atorvastatin Calcium; Calcium, Dietary; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• type II diabetic patients with hypercholesterolemia

Exclusion Criteria:

• liver impairment,

• renal insufficiency,

• coronary artery disease,

• metabolic disorders,

• type I diabetes,

• autoimmune diseases, cancer, infection,

• use of anti-inflammatory drugs,

• recent major surgery,

• weight-loss or modified anti-hypertensive medications 12 weeks or less prior to enrolment,

• ongoing or previous use of lipid-lowering medications (including other statins, fibric acid derivatives, nicotinic acid, cholestyramine, ezetimibe or omega-3 fatty acids) and contraindications to the use of statins.