Type 2 Diabetic Patients Maintained on Statin Therapy

Dyslipidemia Associated With Type II Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784703
• Other study ID #: Statin Therapy
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: December 2020
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 31, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemia Associated With Type II Diabetes Mellitus
• Dyslipidemias

Intervention

Drug:
• Atorvastatin 40 Mg Oral Tablet
40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months
• Rosuvastatin 10 Mg Oral Tablet
10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	El-Gharbia

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hs-CRP (pg/mL)	biomarkers that linking the inflammatory hypothesis with diabetes mellitus and atherosclerosis.	6 months
Primary	sortilin (ng/mL)	Serum Level	6 months
Primary	adiponectin (ng/mL)	Serum Level	6 months
Primary	leptin (ng/mL)	Serum Level	6 months
Secondary	glucose level	fasting blood glucose (FBG) (mg/mL)	6 months
Secondary	glycated hemoglobin	glycated hemoglobin (Hb A1c%)	6 months
Secondary	total cholesterol	TCH: total cholesterol (mg/dL)	6 months
Secondary	low density lipoprotein-cholesterol	LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).	6 months
Secondary	high density lipoprotein-cholesterol	HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).	6 months
Secondary	Triglycerides	Triglycerides (mg/dL).	6 months

External Links

•   The effect of simvastatin-ezetimibe combination therapy on adipose tissue hormones and systemic inflammation in patients with isolated hypercholesterolemia.