Effects of Fenofibrate on Endothelial Progenitor Cells in Diabetes
NCT ID: NCT01927315
Last Updated: 2019-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
41 participants
INTERVENTIONAL
2013-08-31
2019-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Fenofibrate
Fenofibrate 145 mg (Fulcrosupra) oral tablets daily for 12 weeks
Fenofibrate 145 mg
Tablets of Fulcrosupra 145 mg to be taken at 8.00 am daily for 12 weeks.
Placebo
Placebo oral tablets daily for 12 weeks
Placebo
Oral Placebo tablets once daily
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diabetic retinopathy
* Age 18-70
* Both sexes
Exclusion Criteria
* Hereditary muscle disorders
* Uncontrolled hypothyroidism
* Elevated alcohol consumption
* Renal failure
* Hepatic failure
* Allergy to fenofibrate or excipients
* Acute / chronic pancreatitis
* Pregnancy and lactation.
18 Years
65 Years
ALL
No
Sponsors
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Azienda Ospedaliera di Padova
OTHER
University of Padova
OTHER
Responsible Party
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Principal Investigators
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Gian Paolo Fadini, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Padova
Locations
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University Hospital of Padova, Diabetes Outpatient Clinic
Padua, , Italy
Countries
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References
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Bonora BM, Albiero M, Morieri ML, Cappellari R, Amendolagine FI, Mazzucato M, Zambon A, Iori E, Avogaro A, Fadini GP. Fenofibrate increases circulating haematopoietic stem cells in people with diabetic retinopathy: a randomised, placebo-controlled trial. Diabetologia. 2021 Oct;64(10):2334-2344. doi: 10.1007/s00125-021-05532-1. Epub 2021 Aug 9.
Other Identifiers
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2871P
Identifier Type: -
Identifier Source: org_study_id