Evidence map›Paper›PMID 34368894›Full record

Trial reportDiabetologia2021

Fenofibrate increases circulating haematopoietic stem cells in people with diabetic retinopathy: a randomised, placebo-controlled trial.

Benedetta Maria Bonora, Mattia Albiero, Mario Luca Morieri, Roberta Cappellari, Francesco Ivan Amendolagine, Marta Mazzucato, Alberto Zambon, Elisabetta Iori, Angelo Avogaro, Gian Paolo Fadini

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IVRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetologia, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01927315 (Effects of Fenofibrate on Endothelial Progenitor Cell Levels in Diabetic Patients With Retinopathy. A Randomized Controlled Trial.), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01927315 phase4completednot on this map

Effects of Fenofibrate on Endothelial Progenitor Cell Levels in Diabetic Patients With Retinopathy. A Randomized Controlled Trial.

TypeinterventionalSponsorUniversity of PadovaRan2013 to 2019Enrolled41ConditionsDiabetes, Diabetic RetinopathyArmsFenofibrate 145 mg, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Fenofibrate for diabetic retinopathy.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Fenofibrate in ophthalmology: therapeutic efficacy and mechanisms.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026
    Review
  4. Observational
  5. Review
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  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Benedetta Maria BonoraDepartment of Medicine, University of Padova, Padua, Italy.
Mattia AlbieroDepartment of Medicine, University of Padova, Padua, Italy.
Mario Luca MorieriDepartment of Medicine, University of Padova, Padua, Italy.
Roberta CappellariDepartment of Medicine, University of Padova, Padua, Italy.
Francesco Ivan AmendolagineVeneto Institute of Molecular Medicine, Padua, Italy.
Marta MazzucatoDepartment of Medicine, University of Padova, Padua, Italy.
Alberto ZambonDepartment of Medicine, University of Padova, Padua, Italy.
Elisabetta IoriDepartment of Medicine, University of Padova, Padua, Italy.
Angelo AvogaroDepartment of Medicine, University of Padova, Padua, Italy.
Gian Paolo FadiniDepartment of Medicine, University of Padova, Padua, Italy. gianpaolo.fadini@unipd.it.ORCID 0000-0002-6510-2097
University of Padua · ITVeneto Institute of Molecular Medicine · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aim/hypothesisIn two large RCTs, fenofibrate reduced the progression of diabetic retinopathy. We investigated whether fenofibrate increases circulating haematopoietic stem/progenitor cells (HSPCs), which have vascular properties and have been shown to protect from retinopathy.

methodsWe conducted a 12 week parallel-group RCT comparing fenofibrate vs placebo. Patients with diabetic retinopathy and without other conditions that would affect HSPCs were enrolled at a tertiary diabetes outpatient clinic and randomised to receive fenofibrate or placebo based on a computer-generated sequence. Patients and study staff assessing the outcomes were blinded to group assignment. The primary endpoint was the change in the levels of circulating HSPCs, defined by expression of the stem cell markers CD34 and/or CD133. Secondary endpoints were the changes in endothelial progenitor cells, lipids, soluble mediators and gene expression. We used historical data on the association between HSPCs and retinopathy outcomes to estimate the effect of fenofibrate on retinopathy progression.

resultsForty-two participants with diabetic retinopathy were randomised and 41 completed treatment and were analysed (20 in the placebo group and 21 in the fenofibrate group). Mean age was 57.4 years, diabetes duration was 18.2 years and baseline HbA CONCLUSIONS/

interpretationFenofibrate increased HSPC levels in participants with diabetic retinopathy and this mechanism may explain why fenofibrate reduced retinopathy progression in previous studies.

trial registrationClinicalTrials.gov NCT01927315.

Indexed as

AC133 AntigenAdolescentAdultAgedAntigens, CD34BiomarkersBlood GlucoseDiabetic RetinopathyFemaleFenofibrateGlycated HemoglobinHematopoietic Stem CellsHumansHypolipidemic AgentsMaleMiddle AgedAC133 AntigenAntigens, CD34BiomarkersBlood GlucoseFenofibrateGlycated Hemoglobinhemoglobin A1c protein, humanHypolipidemic AgentsPROM1 protein, humanAngiogenesisBone marrowComplicationsHaematopoiesisRegeneration

Identifiers

PMID34368894
OpenAlexW3189012002

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.