Evidence map›Paper›PMID 23439261›Full record

Trial reportJournal of hepatology2013

The liver diseases of lipodystrophy: the long-term effect of leptin treatment.

Elika Safar Zadeh, Andreea O Lungu, Elaine K Cochran, Rebecca J Brown, Marc G Ghany, Theo Heller, David E Kleiner, Phillip Gorden

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

Trial report in Journal of hepatology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 82 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 3 pooled it
11.4field-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

82 citing papers in PubMed, 3 syntheses or guidelines pooled it, 165 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Elika Safar ZadehDiabetes Endocrinology and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, United States.
Andreea O Lungu
Elaine K Cochran
Rebecca J Brown
Marc G Ghany
Theo Heller
David E Kleiner
Phillip Gorden
National Institute of Diabetes and Digestive and Kidney Diseases · USNational Institutes of Health · USNational Cancer Institute · US

Funding

Histology Core LaboratoryZICBC010687 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI CHINQUEE, JOSEPH · 2009 to 2025
$35.1M
Molecular and Clinical Studies of Insulin ResistanceZIADK047050 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI BROWN, REBECCA · 2009 to 2025
$6.1M
Clinical utility of leptin therapy in syndromic forms of insulin resistance.ZIADK047052 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI BROWN, REBECCA · 2009 to 2025
$5.5M
Investigation of non-cirrhotic portal hypertension.ZIADK075008 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI HELLER, THEO · 2009 to 2025
$4.5M
Intramural NIH HHS ZIA DK047050Intramural NIH HHS ZIA DK047052
6 · The paper itself

Abstract

BACKGROUND &

aimsLipodystrophies are hypoleptinemic conditions characterized by fat loss, severe insulin resistance, hypertriglyceridemia, and ectopic fat accumulation. Non-alcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH) are also features of this condition. We studied the spectrum of liver disease in lipodystrophy and the effects of leptin replacement.

methodsThis was an open-label, prospective study of leptin therapy in patients with inherited and acquired lipodystrophy at the National Institutes of Health. Liver biopsies were performed at baseline (N=50) and after leptin replacement (N=27). NASH activity was assessed using the NASH Clinical Research Network (CRN) scoring system. Fasting blood glucose, triglyceride, hemoglobin A1c and liver enzymes were measured at baseline and at the time of the final liver biopsy.

resultsIn leptin-treated patients, 86% met criteria for NASH at baseline, while only 33% had NASH after leptin replacement for 25.8 ± 3.7 months (mean ± SE, p=0.0003). There were significant improvements in steatosis grade (reduction of mean score from 1.8 to 0.9) and ballooning injury scores (from 1.2 to 0.4), with a 44.2% reduction in mean NAFLD activity score (p<0.0001). Patients who already had fibrosis remained stable on leptin replacement. We observed significant improvement in metabolic profile, ALT and AST. In addition to NASH, four patients with acquired generalized lipodystrophy (AGL) had autoimmune hepatitis.

conclusionsThe fundamental liver disease of lipodystrophy is NASH, although autoimmune hepatitis was observed in some patients with AGL. Leptin appears to be a highly effective therapy for NASH in hypoleptinemic lipodystrophic patients.

Indexed as

AdolescentAdultAgedAlanine TransaminaseAspartate AminotransferasesChildCohort StudiesFatty LiverFemaleHepatitis, AutoimmuneHumansLeptinLipodystrophyLiverMaleMetabolomeAlanine TransaminaseAspartate AminotransferasesLeptinmetreleptinRecombinant Proteins

Identifiers

PMID23439261
PMCPMC3924897
OpenAlexW2052222168

What OpenQuestion holds

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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.