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Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

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ClinicalTrials.gov Identifier: NCT01927315
Recruitment Status : Unknown
Verified December 2014 by University of Padova.
Recruitment status was:  Recruiting
First Posted : August 22, 2013
Last Update Posted : December 30, 2014
Sponsor:
Collaborator:
Azienda Ospedaliera di Padova
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Diabetic Retinopathy Drug: Fenofibrate 145 mg Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effects of Fenofibrate on Endothelial Progenitor Cell Levels in Diabetic Patients With Retinopathy. A Randomized Controlled Trial.
Study Start Date : August 2013
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate

Arm Intervention/treatment
Experimental: Fenofibrate
Fenofibrate 145 mg (Fulcrosupra) oral tablets daily for 12 weeks
Drug: Fenofibrate 145 mg
Tablets of Fulcrosupra 145 mg to be taken at 8.00 am daily for 12 weeks.
Other Name: Fulcrosupra 145 mg

Placebo Comparator: Placebo
Placebo oral tablets daily for 12 weeks
Drug: Placebo
Oral Placebo tablets once daily
Other Name: Placebo control




Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  1. Oxidized LDL [ Time Frame: 12 weeks ]
    Change in oxLDL levels in fenofibrate-treated vs placebo-treated patients over 12 weeks.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • Moderate/Severe retinopathy
  • Age 18-65
  • Both sexes

Exclusion Criteria:

  • Age <18 or >65
  • Hereditary muscle disorders
  • Uncontrolled hypothyroidism
  • Elevated alcohol consumption
  • Renal failure
  • Hepatic failure
  • Allergy to fenofibrate or excipients
  • Acute / chronic pancreatitis
  • Pregnancy and lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927315


Contacts
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Contact: Gian Paolo Fadini, MD PhD 0039 049 8214318 gianpaolo.fadini@unipd.it

Locations
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Italy
University Hospital of Padova, Diabetes Outpatient Clinic Recruiting
Padova, Italy, 35100
Contact: Gian Paolo Fadini, MD PhD    0039 049 8214318    gianpaolo.fadini@unipd.it   
Principal Investigator: Gian Paolo Fadini, MD PhD         
Sub-Investigator: Alberto Zambon, MD PhD         
Sponsors and Collaborators
University of Padova
Azienda Ospedaliera di Padova
Investigators
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Principal Investigator: Gian Paolo Fadini, MD PhD University of Padova

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Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT01927315     History of Changes
Other Study ID Numbers: 2871P
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by University of Padova:
Stem cells
Regeneration
Angiogenesis
Prevention

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents