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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