Skip to main content
OpenTrials
Completed

NCT Number: NCT01927315

Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Padova, Diabetes Outpatient Clinic

Padova, 35100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fenofibrate 145 mg

Drug

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

Other names: Fulcrosupra 145 mg

Placebo

Drug

Oral Placebo tablets once daily

Other names: Placebo control

Primary outcomes

  1. Endothelial progenitor cells

    Time frame: 12 weeks

    Change in endothelial progenitor cell (EPC) levels in fenofibrate-treated vs placebo-treated patients over 12 weeks.

  2. Circulating progenitor cells

    Time frame: 12 weeks

    Change in circulating progenitor cell (CPC) levels in fenofibrate-treated vs placebo-treated patients over 12 weeks.

Secondary outcomes

  1. Triglycerides

    Time frame: 12 weeks

    Change in Triglycerideslevels in fenofibrate-treated vs placebo-treated patients over 12 weeks.

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

  • Azienda Ospedaliera di Padova

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2013
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.