Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
Overview
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
Full Title of Study: “Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2020
Detailed Description
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
Interventions
- Drug: Simvastatin 40mg
- Drugs that lower lipid level
- Drug: Fenofibrate 200mg
- Drugs that lower lipid levels
- Drug: Omega 3 fatty acid
- Drugs that lower lipid levels
Arms, Groups and Cohorts
- Active Comparator: Receive oral hypoglycemic +omega 3
- Eicosapentanoic acid + standard treatment
- Active Comparator: Receive oral hypoglycemic +statin
- Simvastatin + standard treatment
- Active Comparator: Receive oral hypoglycemic +fibrate
- Fenofibrate +standard treatment
- No Intervention: Receive oral hypoglycemic only
- Standard treatment only
Clinical Trial Outcome Measures
Primary Measures
- The 80 participants will be evaluated through reduction of macular edema
- Time Frame: 18 weeks
- assessed by ocular coherence tomography
Secondary Measures
- The 80 participants will be evaluated through reduction of cardiovascular risk
- Time Frame: 18 weeks
- assessed by ASCVD risk score
Participating in This Clinical Trial
Inclusion Criteria
- type 2diabetes – Non proliferative diabetic retinopathy Exclusion Criteria:
- Uncontrolled glycemic level – proliferative diabetic retinopathy
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Alaa Hassan ElBaz
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Alaa Hassan ElBaz, Assistant lecturer at beni suef university – Beni-Suef University
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