Type 2 Diabetic Patients Maintained on Statin Therapy

Study Overview
=================
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.

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

Conditions
-----------------
Dyslipidemia Associated With Type II Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Atorvastatin 40 Mg Oral Tablet
* Drug: Rosuvastatin 10 Mg Oral Tablet


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 160 patients were randomly assigned to receive either 40 mg per day atorvastatin tablets (ATROVA group, n= 80) or 10 mg per day Rosuvastatin 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atrovastatin<br>atorvastatin (40 mg per day) for 6 months | Drug: Atorvastatin 40 Mg Oral Tablet<br>* 40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months<br>* Other names: Atorvastatin 40mg tablet per day;|
| Experimental: Rosuvastatin<br>Rosuvastatin (10 mg per day) for 6 months | Drug: Rosuvastatin 10 Mg Oral Tablet<br>* 10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months<br>* Other names: Resovastatin 10 mg daily;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose level | fasting blood glucose (FBG) (mg/mL) | 6 months | 
| glycated hemoglobin | glycated hemoglobin (Hb A1c%) | 6 months | 
| total cholesterol | TCH: total cholesterol (mg/dL) | 6 months | 
| 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 | 
| high density lipoprotein-cholesterol | HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL). | 6 months | 
| Triglycerides | Triglycerides (mg/dL). | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adiponectin, Sortilin, Leptin, Dyslipidemia, Diabetes type II, Rosuvastatin, Atorvastatin