Completed

Effects of Fenofibrate on Endothelial Progenitor Cell Levels in Diabetic Patients With Retinopathy. A Randomized Controlled Trial.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Fenofibrate 145 mg

+ Placebo

Drug
Who is being recruted

Cardiovascular Diseases+9

+ Diabetes Mellitus

+ Diabetic Angiopathies

From 18 to 65 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 4
Interventional
Study Start: August 2013
See protocol details

Summary

Principal SponsorUniversity of Padova
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2013

Actual date on which the first participant was enrolled.

Long-standing diabetes is often complicated by retinopathy. The mechanisms that induce the development of diabetic retinopathy are incompletely understood and include alterations in bone marrow derived vasculogenic cells called "endothelial progenitor cells". Fenofibrate is a PPAR-alpha agonist used for the treatment of mixed dislipidemia and hypertriglyceridemia. In addition to lowering triglyceride-rich lipoproteins, PPAR-alpha agonism with fenofibrate has several additional molecular benefit on the vessel wall, such as reduction of inflammation. In a trial conducted in type 2 diabetic patients, the drug fenofibrate has reduced retinopathy-related endpoints suggesting a direct effect of the drug on the mechanisms that drive the development of this complication. Preliminary data of ours on the effects of fenofibrate on cultured EPC show that this drug has the potential to improve EPC and, consequently, may benefit patients with retinopathy. Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC levels in diabetic patients with retinopathy, compared to placebo.

Official TitleEffects of Fenofibrate on Endothelial Progenitor Cell Levels in Diabetic Patients With Retinopathy. A Randomized Controlled Trial.
NCT01927315
Principal SponsorUniversity of Padova
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

41 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesDiabetic RetinopathyEndocrine System DiseasesEye DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesRetinal DiseasesVascular DiseasesGlucose Metabolism DisordersDiabetes Complications

Criteria

4 inclusion criteria required to participate
Type 1 or type 2 diabetes
Diabetic retinopathy
Age 18-70
Both sexes
9 exclusion criteria prevent from participating
Age <18 or >70 at enrollment
Hereditary muscle disorders
Uncontrolled hypothyroidism
Elevated alcohol consumption
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Fenofibrate 145 mg (Fulcrosupra) oral tablets daily for 12 weeks

Group II

Placebo
Placebo oral tablets daily for 12 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University Hospital of Padova, Diabetes Outpatient Clinic

Padua, ItalyOpen University Hospital of Padova, Diabetes Outpatient Clinic in Google Maps
CompletedOne Study Center