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临床试验/NCT03784703
NCT03784703已完成4 期

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

Damanhour University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
160
试验地点
1
主要终点
hs-CRP (pg/mL)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

prospective, double blind trial

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • type II diabetic patients with hypercholesterolemia

排除标准

  • 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.

研究组 & 干预措施

Atrovastatin

Experimental

atorvastatin (40 mg per day) for 6 months

干预措施: Atorvastatin 40 Mg Oral Tablet (Drug)

Rosuvastatin

Experimental

Rosuvastatin (10 mg per day) for 6 months

干预措施: Rosuvastatin 10 Mg Oral Tablet (Drug)

结局指标

主要结局

hs-CRP (pg/mL)

时间窗: 6 months

biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.

sortilin (ng/mL)

时间窗: 6 months

Serum Level

adiponectin (ng/mL)

时间窗: 6 months

Serum Level

leptin (ng/mL)

时间窗: 6 months

Serum Level

次要结局

  • glucose level(6 months)
  • high density lipoprotein-cholesterol(6 months)
  • Triglycerides(6 months)
  • glycated hemoglobin(6 months)
  • total cholesterol(6 months)
  • low density lipoprotein-cholesterol(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rehab Werida

Clinical Pharmacy Lecturer

Damanhour University

研究点 (1)

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