Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova
• Collaborator: Azienda Ospedaliera di Padova
• Treatments: Fenofibrate

Criteria

Inclusion Criteria:

• Type 1 or type 2 diabetes

• Diabetic retinopathy

• Age 18-70

• Both sexes

Exclusion Criteria:

• Age <18 or >70 at enrollment

• Hereditary muscle disorders

• Uncontrolled hypothyroidism

• Elevated alcohol consumption

• Renal failure

• Hepatic failure

• Allergy to fenofibrate or excipients

• Acute / chronic pancreatitis

• Pregnancy and lactation.