Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo Oral Tablet; Drug: Rosuvastatin10 mg tablet

• Registration Number: NCT03907423
• Lead Sponsor: Rehab Werida

Brief Summary

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

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 Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-04-05
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-09
• Primary Completion: 2021-01-19
• Study Completion: 2021-01-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo Oral Tablet	DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
Rosuvastatin	Rosuvastatin10 mg tablet	DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Damanhour Medical National Institute; 🇪🇬 Damanhūr, N/A = Not Appُlicable, Egypt