Clinical trial NCT03907423: Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin
Official title: Effects of Rosuvastatin on Markers of Atherosclerosis in Diabetic Patients Treated With Glimepiride/Metformin Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: T2DM.
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: serum levels of fetuin A
timeFrame: three months
measure: serum levels of Sortilin
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Medical National Institute
state: N/A = Not Appُlicable
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.