Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 主要终点
- The 80 participants will be evaluated through reduction of macular edema
研究概览
简要总结
The investigator study evaluate the effect of different lipid lowering agents on the progression of diabetic retinopathy and other reduction of cardiovascular risk of diabetic patients
详细描述
The investigator study compare the effect of lipid lowering agent on the enhancement of visual acuity and on reduction of macular edema in patients with diabetic retinopathy and also compare their effect on reduction of cardiovascular risk on diabetic patients via assessment of ASCVD risk score
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2diabetes
- •Non proliferative diabetic retinopathy
排除标准
- •Uncontrolled glycemic level
- •proliferative diabetic retinopathy
研究组 & 干预措施
Receive oral hypoglycemic +fibrate
Fenofibrate +standard treatment
干预措施: Fenofibrate 200mg (Drug)
Receive oral hypoglycemic +omega 3
Eicosapentanoic acid + standard treatment
干预措施: Omega 3 fatty acid (Drug)
Receive oral hypoglycemic +statin
Simvastatin + standard treatment
干预措施: Simvastatin 40mg (Drug)
结局指标
主要结局
The 80 participants will be evaluated through reduction of macular edema
时间窗: 18 weeks
assessed by ocular coherence tomography
次要结局
- The 80 participants will be evaluated through reduction of cardiovascular risk(18 weeks)
研究者
Alaa Hassan ElBaz
Assistant lecturer at beni suef university
Beni-Suef University