Trial reportAlimentary pharmacology & therapeutics2017
Assessment of treatment response in non-alcoholic steatohepatitis using advanced magnetic resonance imaging.
Trial report in Alimentary pharmacology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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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.
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.
An Open-Label Pilot Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Potential of Oral Insulin to Reduce Liver Fat Content and Fibrosis in Patients With Nonalcolholic Steatohepatitis (NASH)
A Double-Blind, Randomized, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Potential impact of ezetimibe on patients with NAFLD/NASH: a meta-analysis of randomized controlled trials.Frontiers in endocrinology · 2024Pooled it
- Clinical Application of Magnetic Resonance Imaging in the Diagnosis of NAFLDCurrent medical imaging · 2026Review
- The Accuracy and Clinical Relevance of the Multi-echo Dixon Technique for Evaluating Changes to Hepatic Steatosis in Patients with Non-alcoholic Fatty Liver Disease Treated with Formulated Food.Magnetic resonance in medical sciences : MRMS : an official journal of Japan Society of Magnetic Resonance in Medicine · 2023Article
- Treatment of NAFLD with intermittent calorie restriction or low-carb high-fat diet - a randomised controlled trial.JHEP reports : innovation in hepatology · 2021Article
- Experimental and Investigational Targeted Therapies for the Management of Fibrosis in NASH: An Update.Journal of experimental pharmacology · 2021Review
- Relationship Between Histological Features of Non-alcoholic Fatty Liver Disease and Ectopic Fat on Magnetic Resonance Imaging in Children and Adolescents.Frontiers in pediatrics · 2021Article
- Si-Wei-Qing-Gan-Tang Improves Non-Alcoholic Steatohepatitis by Modulating the Nuclear Factor-κB Signal Pathway and Autophagy in Methionine and Choline Deficient Diet-Fed Rats.Frontiers in pharmacology · 2020Article
- Liver fat imaging-a clinical overview of ultrasound, CT, and MR imaging.The British journal of radiology · 2018Review
- Liver volume and hepatic adiposity in childhood: relations to body growth and visceral fat.International journal of obesity (2005) · 2018Article
- Role of Magnetic Resonance Imaging in the Monitoring of Patients with Nonalcoholic Fatty Liver Disease: Comparison with Ultrasonography, Lipid Profile, and Body Mass Index.Journal of clinical and experimental hepatologyArticle
- MRI liver fat quantification in an oncologic population: the added value of complex chemical shift-encoded MRI.Clinical imagingArticle
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9 authors.
Funding
Abstract
backgroundMagnetic resonance imaging-derived measures of liver fat and volume are emerging as accurate, non-invasive imaging biomarkers in non-alcoholic steatohepatitis (NASH). Little is known about these measures in relation to histology longitudinally.
aimTo examine any relationship between MRI-derived proton-density fat-fraction (PDFF), total liver volume (TLV), total liver fat index (TLFI), vs. histology in a NASH trial.
methodsThis is a secondary analysis of a 24-week randomised, double-blind, placebo-controlled trial of 50 patients with biopsy-proven NASH randomised to oral ezetimibe 10 mg daily (n = 25) vs. placebo (n = 25). Baseline and post-treatment anthropometrics, biochemical profiling, MRI and biopsies were obtained.
resultsBaseline mean PDFF correlated strongly with TLFI (Spearman's ρ = 0.94, n = 45, P < 0.0001) and had good correlation with TLV (ρ = 0.57, n = 45, P < 0.0001). Mean TLV correlated strongly with TLFI (ρ = 0.78, n = 45, P < 0.0001). After 24 weeks, PDFF remained strongly correlated with TLFI (ρ = 0.94, n = 45, P < 0.0001), maintaining good correlation with TLV (ρ = 0.51, n = 45, P = 0.0004). TLV remained strongly correlated with TLFI (ρ = 0.74, n = 45, P < 0.0001). Patients with Grade 1 vs. 3 steatosis had lower PDFF, TLV, and TLFI (P < 0.0001, P = 0.0003, P < 0.0001 respectively). Regression analysis of changes in MRI-PDFF vs. TLV indicates that 10% reduction in MRI-PDFF predicts 257 mL reduction in TLV.
conclusionsThe MRI-PDFF and TLV strongly correlated with TLFI. Decreases in steatosis were associated with an improvement in hepatomegaly. Lower values of these measures reflect lower histologic steatosis grades. MRI-derived measures of liver fat and volume may be used as dynamic and more responsive imaging biomarkers in a NASH trial, than histology.
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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.