Type 2 Diabetic Patients Maintained on Statin Therapy

Phase 4

Completed

• Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus
• Interventions: Drug: Atorvastatin 40 Mg Oral Tablet; Drug: Rosuvastatin 10 Mg Oral Tablet

• Registration Number: NCT03784703
• Lead Sponsor: Damanhour University

Brief 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-12-13
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-24
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-31
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-30
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• type II diabetic patients with hypercholesterolemia

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atrovastatin	Atorvastatin 40 Mg Oral Tablet	atorvastatin (40 mg per day) for 6 months
Rosuvastatin	Rosuvastatin 10 Mg Oral Tablet	Rosuvastatin (10 mg per day) for 6 months

Primary Outcome Measures

Name	Time	Method
hs-CRP (pg/mL)	6 months	biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.
sortilin (ng/mL)	6 months	Serum Level
adiponectin (ng/mL)	6 months	Serum Level
leptin (ng/mL)	6 months	Serum Level

Secondary Outcome Measures

Name	Time	Method
glucose level	6 months	fasting blood glucose (FBG) (mg/mL)
high density lipoprotein-cholesterol	6 months	HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).
Triglycerides	6 months	Triglycerides (mg/dL).
glycated hemoglobin	6 months	glycated hemoglobin (Hb A1c%)
total cholesterol	6 months	TCH: total cholesterol (mg/dL)
low density lipoprotein-cholesterol	6 months	LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, El-Gharbia, Egypt