Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin

April 12, 2023 updated by: Rehab Werida

Effects of Rosuvastatin on Markers of Atherosclerosis in Diabetic Patients Treated With Glimepiride/Metformin Combination

study effects of rosuvastatin on markers of atherosclerosis, thrombosis, in diabetic patients treated with glimepiride/metformin without coronary artery disease.

This effect will be investigated especially on sortilin ,fetuin-A

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial on 70 patients with DM type 2 will be recruited from Damanhour national medical institute.

  • Subjects will be divided into two group (one arm is DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients) and another arm is DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
  • Determination of serum levels of fetuin A and Sortilin
  • Blood samples will be collected after 3-month after active treatment.
  • Outcomes measurement : Sortilin ,fetuinA, Atherogenic index (AI) and coronary risk index (CRI) .

Methodology

  • Sortilin, fetuinA will be determined by ELISA.
  • Lipid profile.
  • FBG and Hb A1C will be measured.
  • Atherogenic index (AI = LDL-C/HDL-C) and CRI (CRI = TC/HDL-C) will be calculated for all subjects.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • N/A = Not Appُlicable
      • Damanhūr, N/A = Not Appُlicable, Egypt, 31527
        • Damanhour Medical National Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus on oral therapy.
  • Age 21-65 years
  • Life expectancy >1 year.

Exclusion Criteria:

  • Documented CVD
  • Planned surgical intervention.
  • Hypersensitivity to either of the study drug components.
  • Type I diabetes.
  • Current Insulin treatment.
  • Hepatic impairment known hepatic failure.
  • Inability to comply with study protocol.
  • Active malignancy.
  • Chronic inflammation (i.e. inflammatory bowel disease, lupus, inflammatory arthritis, rheumatoid arthritis) or chronic infection (i.e. chronic diabetic foot infection).
  • Pregnancy, lactation or child-bearing potential.
  • Chronic renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosuvastatin
DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients)
Drug: Rosuvastatin10 mg tablet
Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Other Names:
  • Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Placebo Comparator: Placebo Group
DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
Drug: Placebo Oral Tablet
Diabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Other Names:
  • Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum levels of fetuin A
Time Frame: three months
Fetuin-A has a diagnostic potential as a biomarker for liver dysfunction, cardiovascular diseases and disorders associated with metabolic syndrome.
three months
serum levels of Sortilin
Time Frame: three months
Sortilin is involved in lipid metabolism, promotes the development of atherosclerosis, and possibly becomes a potential therapeutic target for atherosclerosis treatment.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehab Werida

Investigators

  • Principal Investigator: Rehab H Werida, Ass.Prof., Damanhour University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

January 19, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rosuvastatin on diabetics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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