Effect of Lipid Lowering Agents on Diabetic Retinopathy a... | NCT04140201

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

NCT04140201

Sponsor

Alaa Hassan ElBaz

Status

Unknown status

Last Update Posted

Jan 18, 2020Actual

Enrollment

80Estimated

Phase

Phase 4

Conditions

Diabetic Retinopathy

Interventions

Simvastatin 40mg
Fenofibrate 200mg
Omega 3 fatty acid

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2020Estimated

Primary Completion Date

Jun 2020Estimated

Completion Date

Aug 2020Estimated

First Submitted Date

Oct 21, 2019

First Submission Date that Met QC Criteria

Oct 24, 2019

First Posted Date

Oct 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2020

Last Update Posted Date

Jan 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alaa Hassan ElBaz, Assistant lecturer at beni suef university, Beni-Suef UniversitySponsor-Investigator

Lead Sponsor

Alaa Hassan ElBazOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Simvastatin 40mg	Drug	Drugs that lower lipid level	Receive oral hypoglycemic +statin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

type 2diabetes
Non proliferative diabetic retinopathy

Exclusion Criteria:

Uncontrolled glycemic level
proliferative diabetic retinopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019821	Simvastatin
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors
D011345	Fenofibrate
D058607	Fibric Acids
D015525	Fatty Acids, Omega-3

Ancestor Terms

ID	Term
D008148	Lovastatin
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided