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

NCT ID: NCT04140201

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2020-08-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Receive oral hypoglycemic +omega 3

Eicosapentanoic acid + standard treatment

Group Type ACTIVE_COMPARATOR

Omega 3 fatty acid

Intervention Type DRUG

Drugs that lower lipid levels

Receive oral hypoglycemic +statin

Simvastatin + standard treatment

Group Type ACTIVE_COMPARATOR

Simvastatin 40mg

Intervention Type DRUG

Drugs that lower lipid level

Receive oral hypoglycemic +fibrate

Fenofibrate +standard treatment

Group Type ACTIVE_COMPARATOR

Fenofibrate 200mg

Intervention Type DRUG

Drugs that lower lipid levels

Receive oral hypoglycemic only

Standard treatment only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Simvastatin 40mg

Drugs that lower lipid level

Intervention Type DRUG

Fenofibrate 200mg

Drugs that lower lipid levels

Intervention Type DRUG

Omega 3 fatty acid

Drugs that lower lipid levels

Intervention Type DRUG

Other Intervention Names

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Statin Fibrate n3 FA

Eligibility Criteria

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Inclusion Criteria

* type 2diabetes
* Non proliferative diabetic retinopathy

Exclusion Criteria

* Uncontrolled glycemic level
* proliferative diabetic retinopathy
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alaa Hassan ElBaz

OTHER

Sponsor Role lead

Responsible Party

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Alaa Hassan ElBaz

Assistant lecturer at beni suef university

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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Diabetic Retinopathy

Identifier Type: -

Identifier Source: org_study_id

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