Type 2 Diabetic Patients Maintained on Statin Therapy

NCT ID: NCT03784703

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-01-31

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.

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Atrovastatin

atorvastatin (40 mg per day) for 6 months

Group Type: EXPERIMENTAL

Atorvastatin 40 Mg Oral Tablet

Intervention Type: DRUG

40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months

Rosuvastatin

Rosuvastatin (10 mg per day) for 6 months

Group Type: EXPERIMENTAL

Rosuvastatin 10 Mg Oral Tablet

Intervention Type: DRUG

10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months

Interventions

Atorvastatin 40 Mg Oral Tablet

40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months

Intervention Type: DRUG

Rosuvastatin 10 Mg Oral Tablet

10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months

Intervention Type: DRUG

Other Intervention Names

Atorvastatin 40mg tablet per day; Resovastatin 10 mg daily

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: collaborator

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Werida

Clinical Pharmacy Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rehab Werida, Lecturer

Role: STUDY_DIRECTOR

Damanhour University

Locations

Tanta University Hospital

Tanta, El-Gharbia, Egypt

Countries

Egypt

References

Krysiak R, Zmuda W, Okopien B. The effect of simvastatin-ezetimibe combination therapy on adipose tissue hormones and systemic inflammation in patients with isolated hypercholesterolemia. Cardiovasc Ther. 2014 Apr;32(2):40-6. doi: 10.1111/1755-5922.12057.

Reference Type: BACKGROUND

PMID: 24354929 (View on PubMed)

Other Identifiers

Statin Therapy

Identifier Type: -

Identifier Source: org_study_id