Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

Phase 4

Completed

• Conditions: Diabetes; Diabetic Retinopathy
• Interventions: Drug: Fenofibrate 145 mg; Drug: Placebo

• Registration Number: NCT01927315
• Lead Sponsor: University of Padova

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-21
• Study First Posted: 2013-08-22
• Primary Completion: 2019-10
• Status Verified: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-17
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fenofibrate	Fenofibrate 145 mg	Fenofibrate 145 mg (Fulcrosupra) oral tablets daily for 12 weeks
Placebo	Placebo	Placebo oral tablets daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Circulating progenitor cells	12 weeks	Change in circulating progenitor cell (CPC) levels in fenofibrate-treated vs placebo-treated patients over 12 weeks.
Endothelial progenitor cells	12 weeks	Change in endothelial progenitor cell (EPC) levels in fenofibrate-treated vs placebo-treated patients over 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Triglycerides	12 weeks	Change in Triglycerideslevels in fenofibrate-treated vs placebo-treated patients over 12 weeks.

Trial Locations

Locations (1)

University Hospital of Padova, Diabetes Outpatient Clinic; 🇮🇹 Padova, Italy