Rosuvastatin on Diabetic Patients Treated With Glimepiride/Metformin

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Rosuvastatin10 mg tablet
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum levels of fetuin A | 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 | Sortilin is involved in lipid metabolism, promotes the development of atherosclerosis, and possibly becomes a potential therapeutic target for atherosclerosis treatment. | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T2DM.