Evidence map›Paper›PMID 30854694›Full record

Trial reportAlimentary pharmacology & therapeutics2019

Relationship between resolution of non-alcoholic steatohepatitis and changes in lipoprotein sub-fractions: a post-hoc analysis of the PIVENS trial.

Kathleen E Corey, Laura A Wilson, Akif Altinbas, Katherine P Yates, David E Kleiner, Raymond T Chung, Ronald M Krauss, Naga Chalasani, NASH Clinical Research Network

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Alimentary pharmacology & therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.2field-weighted citation impact, top 8% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Laparoscopic sleeve gastrectomy altersScientific reports · 2021
    Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Review
  8. Evolution of Fatty Liver Disease and Relationship With Lipoproteins and Clinical Outcomes in Hepatitis B/Human Immunodeficiency Virus Coinfection.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  9. Review
  10. Article
  11. Review
  12. Review
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  14. Review
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

9 authors at 4 institutions in 1 country.

Kathleen E CoreyHarvard Medical School, Massachusetts General Hospital, Boston, Massachusetts.ORCID 0000-0003-2882-7264
Laura A WilsonJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Akif AltinbasHarvard Medical School, Massachusetts General Hospital, Boston, Massachusetts.
Katherine P YatesJohns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
David E KleinerLaboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Raymond T ChungHarvard Medical School, Massachusetts General Hospital, Boston, Massachusetts.
Ronald M KraussChildren's Hospital Oakland Research Institute, Oakland, California.
Naga ChalasaniIndiana University School of Medicine, Indianapolis, Indiana.ORCID 0000-0003-4082-3178
NASH Clinical Research Network
Harvard University · USJohns Hopkins University · USIndiana University School of MedicineNational Institutes of Health · US

Funding

Clinical and Translational Science Collaborative of ClevelandUL1TR002548 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2018 to 2022
$35.5M
Continuation of the Non-Alcoholic Steatohepatitis Clinical Research Network (NASHU01DK061730 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI TONASCIA, JAMES A · 2002 to 2018
$23.2M
Postmortem PathologyZICBC010685 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI KLEINER, DAVID ERWIN · 2009 to 2025
$14.3M
Non Alcoholic Steatohepatitis Clinical Research NetworkU01DK061732 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI Srinivasan Dasarathy · 2002 to 2026
$12.2M
VEDS Year2-Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Data Coordinating CenterU24DK061730 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI JEANNE M CLARK, David M Shade · 2019 to 2026
$11.3M
Pathogenesis, prognosis, and treatment of NAFLD patientsU01DK061713 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI ANNA MAE ELIZABETH DIEHL · 2002 to 2026
$10.3M
Patient-Oriented Research on Hepatitis in Special PopulationsK24DK078772 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI CHUNG, RAYMOND T · 2007 to 2016
$1.6M
The Impact of Obstructive Sleep Apnea on Non-Alcoholic Fatty Liver DiseaseK23DK099422 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI COREY, KATHLEEN ELIZABETH · 2013 to 2017
$938k
NCATS NIH HHS UL1 TR002548NIDDK NIH HHS K23 DK099422NIDDK NIH HHS K24 DK078772NIDDK NIH HHS U01 DK061713NIDDK NIH HHS U01 DK061730NIDDK NIH HHS U01 DK061732NIDDK NIH HHS U24 DK061730NIH HHS DK078772
6 · The paper itself

Abstract

backgroundDyslipidaemia is frequent in non-alcoholic steatohepatitis (NASH); however, it is unclear if improvement in liver histology is associated with favourable changes in cardiovascular disease (CVD) risk.

aimsTo evaluate the relationship of NASH resolution and lipoprotein subfraction levels, markers of endothelial dysfunction, and macrophage activation.

methodsOne hundred and seventeen individuals with NASH who participated in the Pioglitazone vs Vitamin E vs Placebo for the Treatment of Nondiabetic Patients with NASH (PIVENS) trial with paired liver biopsies and serum samples available at baseline and after 96 weeks of treatment were included. Participants in the PIVENS trials received vitamin E, pioglitazone, or placebo for 96 weeks. Lipoprotein subfraction levels, intracellular adhesion molecule 1 (ICAM-1), vascular cellular adhesion molecule 1 (VCAM-1), E-selectin, and sCD163 levels were assessed at baseline and week 96 and their relationship with NASH resolution was examined.

resultsFifty-seven individuals had NASH resolution and 60 individuals did not have resolution of NASH. NASH resolution was associated with favourable changes in lipoprotein subfraction levels compared to those without NASH resolution. Individuals with resolution of NASH had a significantly increased mean peak LDL diameter (ratio of geometric means [96 weeks vs baseline] 1.007 vs 0.996, P = 0.004), and higher frequency of LDL phenotype A (58% vs 33%, P = 0.003) at week 96, after adjustment for relevant co-variates including treatment group. No differences in VCAM, ICAM, E-selectin, or sCD163 levels by NASH resolution were found.

conclusionsNASH resolution is associated with favourable changes in a subset of serum lipoprotein levels. More studies are warranted to understand if these favourable changes are associated with decreased risk of CVD.

Indexed as

AdultBiomarkersBiopsyDyslipidemiasE-SelectinFemaleHumansIntercellular Adhesion Molecule-1LipoproteinsMacrophage ActivationMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseParticle SizePioglitazoneRemission InductionBiomarkersE-SelectinIntercellular Adhesion Molecule-1LipoproteinsPioglitazoneSELE protein, humanVascular Cell Adhesion Molecule-1Vitamin E

Identifiers

PMID30854694
PMCPMC6461513
OpenAlexW2921816737

What OpenQuestion holds

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Registered trials

None linked

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.