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Type 2 Diabetic Patients Maintained on Statin Therapy

NCT03784703 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-01-05

No results posted yet for this study

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.

Conditions

  • Dyslipidemia Associated With Type II Diabetes Mellitus

Interventions

DRUG

Atorvastatin 40 Mg Oral Tablet

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

DRUG

Rosuvastatin 10 Mg Oral Tablet

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

Sponsors & Collaborators

  • Tanta University

    collaborator OTHER

  • Damanhour University

    lead OTHER

Principal Investigators

  • Rehab Werida, Lecturer · Damanhour University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-01-30
Completion
2020-01-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03784703 on ClinicalTrials.gov