Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927315
• Other study ID #: 2871P
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Fenofibrate 145 mg
Tablets of Fulcrosupra 145 mg to be taken at 8.00 am daily for 12 weeks.
• Placebo
Oral Placebo tablets once daily

Locations

Country	Name	City	State
Italy	University Hospital of Padova, Diabetes Outpatient Clinic	Padova

Sponsors (2)

Lead Sponsor	Collaborator
University of Padova	Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial progenitor cells	Change in endothelial progenitor cell (EPC) levels in fenofibrate-treated vs placebo-treated patients over 12 weeks.	12 weeks
Primary	Circulating progenitor cells	Change in circulating progenitor cell (CPC) levels in fenofibrate-treated vs placebo-treated patients over 12 weeks.	12 weeks
Secondary	Triglycerides	Change in Triglycerideslevels in fenofibrate-treated vs placebo-treated patients over 12 weeks.	12 weeks