NCT03784703

Type 2 Diabetic Patients Maintained on Statin Therapy

Efficacy of Atorvastatin Versus Rosuvastatin on LV Function and Inflammatory Biomarkers in Type 2 Diabetic Patients With Dyslipidemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

a prospective, double blind trial, conducted between January 2018 and January 2020. Participants were enrolled if they had moderate cardiovascular risk (Framingham risk score of 10-20%), in other words 2 or more major risk factors for coronary artery disease (CAD), and LDL-cholesterol level ≥100 mg/dl. All patients gave informed consent before entering the study. Of 150 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin (Rosuvastatin Calcium®, Chemipharm Co. Cairo, Egypt) tablets (ROSUVA group, n= 80) as recommended in NCEP ATP III (21). Patients included in the study were maintained on oral hypoglycemic agents (OHA) according to their treatment regimen. Clinical and biochemical assessment was done at baseline and after 6 months. Serum High-sensitivity CRP (hsCRP), sortilin, Adiponectin and Leptin level was determined using ELISA Kit. Blood pressure (BP) and anthropometrical parameters, such as body-mass index (BMI) were calculated using the equation (BMI = weight (kg)/height (m2). Blood pressure was measured twice, after keeping participants in a sitting position for 15 min. The mean value of two consecutive measurements with 5 min intervals was used for study purposes. HbA1c% was determined by ion exchange method. Serum triglycerides (TGs), total cholesterol (TCH), and high-density lipoprotein cholesterol (HDL-C) were determined colorimetrically. Low-density lipoprotein-cholesterol (LDL-C) was calculated according to Friedewald formula. Atherogenic Index (AI) is calculated through the following: Atherogenic Index = TCH/HDL-C as TCH/HDL-C ratio is an excellent CVD risk predictor and a good biomarker for deciding on the intensity and the need for therapeutic intervention.

Conditions

• Dyslipidemia Associated With Type II Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Atorvastatin 40 Mg Oral Tablet	40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months
DRUG	Rosuvastatin 10 Mg Oral Tablet	10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-01-30
• Completion: 2020-01-31
• First posted: 2018-12-24
• Last updated: 2021-01-05

Locations

1 site across 1 country: Egypt