Evidence map›Paper›PMID 27151177›Full record

Trial reportJournal of hepatology2016

Sitagliptin vs. placebo for non-alcoholic fatty liver disease: A randomized controlled trial.

Jeffrey Cui, Len Philo, Phirum Nguyen, Heather Hofflich, Carolyn Hernandez, Ricki Bettencourt, Lisa Richards, Joanie Salotti, Archana Bhatt, Jonathan Hooker and 5 more

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hepatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 154 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
154citing papers in PubMed, 11 pooled it
28.8field-weighted citation impact, top 1% 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

154 citing papers in PubMed, 11 syntheses or guidelines pooled it, 321 citations in OpenAlex.

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94 more citing papers are in PubMed but not listed here.

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

15 authors at 2 institutions in 1 country.

Jeffrey CuiNAFLD Research Center, Department of Medicine, University of California at San Diego, La Jolla, CA, United States.
Len PhiloNaval Medical Center San Diego, San Diego, CA, United States.
Phirum NguyenNAFLD Research Center, Department of Medicine, University of California at San Diego, La Jolla, CA, United States.
Heather HofflichDivision of General Internal Medicine, Department of Medicine, University of California at San Diego, La Jolla, CA, United States.
Carolyn HernandezNAFLD Research Center, Department of Medicine, University of California at San Diego, La Jolla, CA, United States.
Ricki BettencourtNAFLD Research Center, Department of Medicine, University of California at San Diego, La Jolla, CA, United States; Division of Epidemiology, Department of Family and Preventive Medicine, University of California at San Diego, La Jolla, CA, United States.
Lisa RichardsNAFLD Research Center, Department of Medicine, University of California at San Diego, La Jolla, CA, United States; Division of Gastroenterology, Department of Medicine, University of California at San Diego, La Jolla, CA, United States.
Joanie SalottiNAFLD Research Center, Department of Medicine, University of California at San Diego, La Jolla, CA, United States; Division of Gastroenterology, Department of Medicine, University of California at San Diego, La Jolla, CA, United States.
Archana BhattNAFLD Research Center, Department of Medicine, University of California at San Diego, La Jolla, CA, United States.
Jonathan HookerLiver Imaging Group, Department of Radiology, University of California at San Diego, La Jolla, CA, United States.
William HaufeLiver Imaging Group, Department of Radiology, University of California at San Diego, La Jolla, CA, United States.
Catherine HookerLiver Imaging Group, Department of Radiology, University of California at San Diego, La Jolla, CA, United States.
David A BrennerDivision of Gastroenterology, Department of Medicine, University of California at San Diego, La Jolla, CA, United States.
Claude B SirlinLiver Imaging Group, Department of Radiology, University of California at San Diego, La Jolla, CA, United States.
Rohit LoombaNAFLD Research Center, Department of Medicine, University of California at San Diego, La Jolla, CA, United States; Division of Epidemiology, Department of Family and Preventive Medicine, University of California at San Diego, La Jolla, CA, United States; Division of Gastroenterology, Department of Medicine, University of California at San Diego, La Jolla, CA, United States; San Diego Integrated NAFLD Research Consortium (SINC), United States. Electronic address: roloomba@ucsd.edu.
University of California, San Diego · USNaval Medical Center San Diego · US

Funding

QUS Technology for Diagnosis and Grading of Hepatic Steatosis in NAFLDR01DK106419 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LOOMBA, ROHIT, SIRLIN, CLAUDE B · 2015 to 2019
$3.4M
San Diego Clinical and Translational Research InstituteTL1TR000098 · NCATS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FIRESTEIN, GARY S · 2012 to 2014
$860k
GENETIC EPIDEMIOLOGY OF NONALCOHOLIC FATTY LIVER DISEASEK23DK090303 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LOOMBA, ROHIT · 2011 to 2014
$721k
NCATS NIH HHS TL1 TR000098NIDDK NIH HHS K23 DK090303NIDDK NIH HHS R01 DK106419
6 · The paper itself

Abstract

BACKGROUND &

aimsUncontrolled studies show sitagliptin, an oral DPP-4 inhibitor, may improve alanine aminotransferase and liver histology in non-alcoholic fatty liver disease (NAFLD) patients. We aimed to compare sitagliptin vs. the efficacy of a placebo in reducing liver fat measured by MRI-derived proton density-fat fraction (MRI-PDFF).

methodsThis randomized, double-blind, allocation-concealed, placebo-controlled trial included 50 NAFLD patients with prediabetes or early diabetes randomized to sitagliptin orally 100mg/day or placebo for 24weeks. Primary outcome was liver fat change measured by MRI-PDFF in colocalized regions of interest within each of nine liver segments. Additional advanced assessments included MR spectroscopy (MRS) for internal validation of MRI-PDFF's accuracy, and magnetic resonance elastography (MRE) and FIBROSpect® II to assess liver fibrosis.

resultsSitagliptin was not significantly better than placebo in reducing liver fat measured by MRI-PDFF (mean difference between sitagliptin and placebo arms: -1.3%, p=0.4). Compared to baseline, there were no significant differences in end-of-treatment MRI-PDFF for sitagliptin (18.1% to 16.9%, p=0.27) or placebo (16.6% to 14.0%, p=0.07). The groups had no significant differences for changes in alanine aminotransferase, aspartate aminotransferase, low-density lipoprotein, homeostatic model assessment insulin resistance, and MRE-derived liver stiffness. In both groups at baseline and post-treatment, MRI-PDFF and MRS showed robust correlation coefficients ranging from r(2)=0.96 to r(2)=0.99 (p<0.0001), demonstrating the strong internal validity of the findings. FIBROSpect® II showed no changes in the sitagliptin group but was significantly increased in the placebo group (p=0.03).

conclusionsSitagliptin was safe but not better than placebo in reducing liver fat in prediabetic or diabetic patients with NAFLD. LAY SUMMARY: In a randomized, double-blind, placebo-controlled study, the anti-diabetic drug sitagliptin was no more effective than placebo for improving liver fat and liver fibrosis in patients with non-alcoholic fatty liver disease. This study demonstrates that non-invasive magnetic resonance imaging techniques, including magnetic resonance imaging-proton density-fat fraction and magnetic resonance elastography, can be used to assess treatment response in non-alcoholic fatty liver disease clinical trials.

Indexed as

Non-alcoholic Fatty Liver DiseaseDouble-Blind MethodElasticity Imaging TechniquesHumansLiverMagnetic Resonance ImagingSitagliptin PhosphateSitagliptin PhosphateBiomarkerFat mappingFibrosisHepatic steatosisImagingLipid lowering therapyMagnetic resonance elastographyMRI-proton-density-fat-fraction (PDFF)NAFLDNon-alcoholic steatohepatitisNon-invasive assessmentSitagliptin

Identifiers

PMID27151177
PMCPMC5081213
OpenAlexW2397785404

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.