Effects of Rosuvastatin on Markers of Atherosclerosis in Diabetic Patients Treated With Glimepiride/Metformin Combination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- serum levels of fetuin A
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus on oral therapy.
- •Age 21-65 years
- •Life expectancy >1 year.
排除标准
- •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
研究组 & 干预措施
Rosuvastatin
DM-type 2 patients who will receive rosuvastatin -metformin-glimepiride combination (40 patients)
干预措施: Rosuvastatin10 mg tablet (Drug)
Placebo Group
DM-type 2 patient who will receive glimepiride-metformin combination (30 patients).
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
serum levels of fetuin A
时间窗: 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
时间窗: three months
Sortilin is involved in lipid metabolism, promotes the development of atherosclerosis, and possibly becomes a potential therapeutic target for atherosclerosis treatment.
次要结局
未报告次要终点
研究者
Rehab Werida
Principal Investigator
Damanhour University