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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

Tracking Information
First Submitted Date  ICMJE August 19, 2013
First Posted Date  ICMJE August 22, 2013
Last Update Posted Date December 30, 2014
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
Endothelial progenitor cells [ Time Frame: 12 weeks ]
Change in endothelial progenitor cell (EPC) levels in fenofibrate-treated vs placebo-treated patients over 12 weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01927315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
Oxidized LDL [ Time Frame: 12 weeks ]
Change in oxLDL levels in fenofibrate-treated vs placebo-treated patients over 12 weeks.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes
Official Title  ICMJE Effects of Fenofibrate on Endothelial Progenitor Cell Levels in Diabetic Patients With Retinopathy. A Randomized Controlled Trial.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE
  • Diabetes
  • Diabetic Retinopathy
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Oral Placebo tablets once daily
    Other Name: Placebo control
Study Arms  ICMJE
  • Experimental: Fenofibrate
    Fenofibrate 145 mg (Fulcrosupra) oral tablets daily for 12 weeks
    Intervention: Drug: Fenofibrate 145 mg
  • Placebo Comparator: Placebo
    Placebo oral tablets daily for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 21, 2013)
38
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01927315
Other Study ID Numbers  ICMJE 2871P
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Padova
Study Sponsor  ICMJE University of Padova
Collaborators  ICMJE Azienda Ospedaliera di Padova
Investigators  ICMJE
Principal Investigator: Gian Paolo Fadini, MD PhD University of Padova
PRS Account University of Padova
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP