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

NCT04140201 | Unknown Phase 4

• 1 other identifier: Diabetic Retinopathy
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• The 80 participants will be evaluated through reduction of macular edema

  assessed by ocular coherence tomography

  18 weeks

Secondary Outcomes (1)

• The 80 participants will be evaluated through reduction of cardiovascular risk

  18 weeks

Study Arms (4)

Receive oral hypoglycemic +omega 3

ACTIVE COMPARATOR

Eicosapentanoic acid + standard treatment

Drug: Omega 3 fatty acid

Receive oral hypoglycemic +statin

ACTIVE COMPARATOR

Simvastatin + standard treatment

Drug: Simvastatin 40mg

Receive oral hypoglycemic +fibrate

ACTIVE COMPARATOR

Fenofibrate +standard treatment

Drug: Fenofibrate 200mg

Receive oral hypoglycemic only

NO INTERVENTION

Standard treatment only

Interventions

Simvastatin 40mg DRUG

Drugs that lower lipid level

Also known as: Statin

Receive oral hypoglycemic +statin

Fenofibrate 200mg DRUG

Drugs that lower lipid levels

Also known as: Fibrate

Receive oral hypoglycemic +fibrate

Omega 3 fatty acid DRUG

Drugs that lower lipid levels

Also known as: n3 FA

Receive oral hypoglycemic +omega 3

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• type 2diabetes
• Non proliferative diabetic retinopathy

You may not qualify if:

• Uncontrolled glycemic level
• proliferative diabetic retinopathy

Sponsors & Collaborators

• Alaa Hassan ElBaz: lead

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Simvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Fenofibrate; Fibric Acids; Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Phenols; Ketones; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer at beni suef university

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 25, 2019
• Study Start: February 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: August 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01