NCT01927315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

6.2 years

First QC Date

August 19, 2013

Last Update Submit

December 17, 2019

Conditions

DiabetesDiabetic Retinopathy

Keywords

Stem cellsRegenerationAngiogenesisPrevention

Outcome Measures

Primary Outcomes (2)

  • Endothelial progenitor cells

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

    12 weeks

  • Circulating progenitor cells

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

    12 weeks

Secondary Outcomes (1)

  • Triglycerides

    12 weeks

Study Arms (2)

Fenofibrate

EXPERIMENTAL

Fenofibrate 145 mg (Fulcrosupra) oral tablets daily for 12 weeks

Drug: Fenofibrate 145 mg

Placebo

PLACEBO COMPARATOR

Placebo oral tablets daily for 12 weeks

Drug: Placebo

Interventions

Fenofibrate 145 mgDRUG

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

Also known as: Fulcrosupra 145 mg
Fenofibrate
PlaceboDRUG

Oral Placebo tablets once daily

Also known as: Placebo control
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 or type 2 diabetes
  • Diabetic retinopathy
  • Age 18-70
  • Both sexes

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Padova, Diabetes Outpatient Clinic

Padua, 35100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 34368894DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Officials

  • Gian Paolo Fadini, MD PhD

    University of Padova

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blind
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 22, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Locations

IT(1)