Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients

January 15, 2020 updated by: Alaa Hassan ElBaz

Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • type 2diabetes
  • Non proliferative diabetic retinopathy

Exclusion Criteria:

  • Uncontrolled glycemic level
  • proliferative diabetic retinopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Receive oral hypoglycemic +omega 3
Eicosapentanoic acid + standard treatment
Drug: Omega 3 fatty acid
Drugs that lower lipid levels
Other Names:
  • n3 FA
Active Comparator: Receive oral hypoglycemic +statin
Simvastatin + standard treatment
Drug: Simvastatin 40mg
Drugs that lower lipid level
Other Names:
  • Statin
Active Comparator: Receive oral hypoglycemic +fibrate
Fenofibrate +standard treatment
Drug: Fenofibrate 200mg
Drugs that lower lipid levels
Other Names:
  • Fibrate
No Intervention: Receive oral hypoglycemic only
Standard treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 80 participants will be evaluated through reduction of macular edema
Time Frame: 18 weeks
assessed by ocular coherence tomography
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The 80 participants will be evaluated through reduction of cardiovascular risk
Time Frame: 18 weeks
assessed by ASCVD risk score
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alaa Hassan ElBaz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetic Retinopathy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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