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Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

NCT01927315 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-12-19

No results posted yet for this study

Summary

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 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.

Herein, the investigators hypothesize that fenofibrate treatment can increase circulating EPC levels in diabetic patients with retinopathy, compared to placebo.

Conditions

Interventions

DRUG

Fenofibrate 145 mg

Tablets of Fulcrosupra 145 mg to be taken at 8.00 am daily for 12 weeks.

DRUG

Placebo

Oral Placebo tablets once daily

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • University of Padova

    lead OTHER

Principal Investigators

  • Gian Paolo Fadini, MD PhD · University of Padova

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01927315 on ClinicalTrials.gov