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Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes

Sponsor
University of Padova (Other)
Overall Status
Completed
CT.gov ID
NCT01927315
Collaborator
Azienda Ospedaliera di Padova (Other)
41
Enrollment
1
Location
2
Arms
76
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Single blind
Primary Purpose:
Basic Science
Official Title:
Effects of Fenofibrate on Endothelial Progenitor Cell Levels in Diabetic Patients With Retinopathy. A Randomized Controlled Trial.
Actual Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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 Names:
  • Fulcrosupra 145 mg

    		•
    Placebo Comparator: Placebo

    Placebo oral tablets daily for 12 weeks

    Drug: Placebo
    Oral Placebo tablets once daily
    Other Names:
  • Placebo control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endothelial progenitor cells [12 weeks]

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

    2. Circulating progenitor cells [12 weeks]

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

    Secondary Outcome Measures

    1. Triglycerides [12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Padova, Diabetes Outpatient Clinic Padova Italy 35100

    Sponsors and Collaborators

    • University of Padova
    • Azienda Ospedaliera di Padova

    Investigators

    • Principal Investigator: Gian Paolo Fadini, MD PhD, University of Padova

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Padova
    ClinicalTrials.gov Identifier:
    NCT01927315
    Other Study ID Numbers:
    • 2871P
    First Posted:
    Aug 22, 2013
    Last Update Posted:
    Dec 19, 2019
    Last Verified:
    Dec 1, 2019
    Keywords provided by University of Padova
    Stem cells
    Regeneration
    Angiogenesis
    Prevention
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Fenofibrate

    Study Results

    No Results Posted as of Dec 19, 2019