Comparison of the Effect of Fenofibrate Versus Curcumin in Type 2 Diabetic Patients Treated With Glimepiride
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- fetuin-A (mg/L)
研究概览
简要总结
The aim of this study is to evaluate the effect of fenofibrate versus curcumin on glycemic status, lipids profile, hs-CRP, sirtuin-1 and fetuin-A in type 2 diabetic patients who are taking glimepiride.
详细描述
Method & Proposal Steps
1- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University. 2- All participants agreed to take part in this clinical study and provide informed consent. 3- (60) Patients with DM type 2 who's taking Glimepiride will be enrolled from Internal Medicine Department, Tanta University Hospital. 4- Serum samples will be collected for measuring the biomarkers. 5- All enrolled patients will be mentioned as two groups; Group I are patients who will be prescribed glimepiride plus fenofibrate. Group II are patients who will be prescribed glimepiride plus curcumin. 6- All patients will be followed up during 3 months' period. 7- At the end of 3 months on the new regimen, steps 4 will be repeated. 8- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9- Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 3 months and lipid profile. 10- Results, conclusion, discussion and recommendations will be given.
Methodology Serum levels of fetuin-A, and Sirtuin1 (SIRT1) will be measured ELISA. Lipid profile. Fasting Blood glucose and 2 hrs postprandial Blood Glucose. Hb A1C will be measured. BMI of the patients will be measured before and after the study. High sensitivity C-reactive protein (hs-CRP) will be measured.
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)
盲法说明
Double Blind
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 Patients with type 2 DM diagnosed clinically.
- •The age ranged from 35 to 70 years.
- •There are no limits to the duration of DM and gender.
- •HbA1c ≥ 7
排除标准
- •Other types of DM
- •Hypersensitivity to the drug
- •Abnormal liver function
- •Patients with renal impairment (eGFR ≤ 60 ml/min)
- •Addition of any antidiabetic medications or insulin during follows up.
- •Pregnancy, lactation or child-bearing potential.
- •No insulin therapy and no use of antioxidants, multivitamin.
研究组 & 干预措施
Group I
Glimepiride (4 mg) per Day
干预措施: Glimepiride Tablets (Drug)
Group II
Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day
干预措施: glimepiride plus fenofibrate (Drug)
Group III
Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day
干预措施: glimepiride plus curcumin (Drug)
结局指标
主要结局
fetuin-A (mg/L)
时间窗: three months
human Fetuin A protein
Sirtuin1 (SIRT1) (ng/ml)
时间窗: three months
human Sirtuin1 a Protein - Recombinant human SIRT1 protein
次要结局
- Total Cholesterol (mg/dl)(Three Months)
- Triglyceride (mg/dl)(Three Months)
研究者
Rehab Werida
Principal Investigator
Damanhour University