Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin

NCT03907423 — Not applicable, Completed, 70 participants, Rehab Werida

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

Registry	NCT03907423
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	70 (Actual)
Sponsor	Rehab Werida (Other)
Conditions	Diabetes Mellitus, Type 2
Interventions	Rosuvastatin10 mg tablet, Placebo Oral Tablet (Drug)
Dates	start 2019-04-01, primary completion 2021-01-19, completion 2021-01-31, first posted 2019-04-09, last updated 2023-04-14
Locations	1 site in Egypt

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Rosuvastatin	Experimental	Drug: Rosuvastatin10 mg tablet	DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients)
Placebo Group	Placebo comparator	Drug: Placebo Oral Tablet	DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).

Rosuvastatin10 mg tablet (Drug), also known as Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral: Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
Placebo Oral Tablet (Drug), also known as Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral: Diabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 21 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Damanhour Medical National Institute	Damanhūr, N/A = Not Appُlicable	Egypt

+Publications

Oh TJ, Ahn CH, Kim BR, Kim KM, Moon JH, Lim S, Park KS, Lim C, Jang H, Choi SH. Circulating sortilin level as a potential biomarker for coronary atherosclerosis and diabetes mellitus. Cardiovasc Diabetol. 2017 Jul 20;16(1):92. doi: 10.1186/s12933-017-0568-9. PMID 28728579
Dabrowska AM, Tarach JS, Wojtysiak-Duma B, Duma D. Fetuin-A (AHSG) and its usefulness in clinical practice. Review of the literature. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Sep;159(3):352-9. doi: 10.5507/bp.2015.018. Epub 2015 Apr 24. PMID 25916279

+Investigators

Rehab H Werida, Ass.Prof., Principal investigator, Damanhour University