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Completed

NCT Number: NCT03784703

Type 2 Diabetic Patients Maintained on Statin Therapy

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.

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Key information

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University Hospital

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atorvastatin 40 Mg Oral Tablet

Drug

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

Other names: Atorvastatin 40mg tablet per day

Rosuvastatin 10 Mg Oral Tablet

Drug

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

Other names: Resovastatin 10 mg daily

Primary outcomes

  1. hs-CRP (pg/mL)

    Time frame: 6 months

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

  2. sortilin (ng/mL)

    Time frame: 6 months

    Serum Level

  3. adiponectin (ng/mL)

    Time frame: 6 months

    Serum Level

  4. leptin (ng/mL)

    Time frame: 6 months

    Serum Level

Secondary outcomes

  1. glucose level

    Time frame: 6 months

    fasting blood glucose (FBG) (mg/mL)

  2. glycated hemoglobin

    Time frame: 6 months

    glycated hemoglobin (Hb A1c%)

  3. total cholesterol

    Time frame: 6 months

    TCH: total cholesterol (mg/dL)

  4. low density lipoprotein-cholesterol

    Time frame: 6 months

    LDL-C: low density lipoprotein-cholesterol (mg/dL), HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).

  5. high density lipoprotein-cholesterol

    Time frame: 6 months

    HDL-C: high density lipoprotein-cholesterol (mg/dL); Triglycerides (mg/dL).

  6. Triglycerides

    Time frame: 6 months

    Triglycerides (mg/dL).

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Tanta University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2018
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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