Evidence map›Paper›PMID 25536669›Full record

Trial reportAntiviral therapy2016

The effect of recombinant human growth hormone with or without rosiglitazone on hepatic fat content in HIV-1-infected individuals: a randomized clinical trial.

Donald P Kotler, Qing He, Ellen S Engelson, Jeanine B Albu, Marshall J Glesby

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antiviral therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00130286 (Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Growth Hormone and/or Rosiglitazone in the Treatment of Human Immunodeficiency Virus-Associated Visceral Adiposity and Insulin Resistance), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.9field-weighted citation impact, top 21% 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.

NCT00130286 phase1 / phase2completednot on this map

Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Growth Hormone and/or Rosiglitazone in the Treatment of Human Immunodeficiency Virus-Associated Visceral Adiposity and Insulin Resistance

TypeinterventionalSponsorWeill Medical College of Cornell UniversityRan2005 to 2010Enrolled77ConditionsHIV-Associated Lipodystrophy Syndrome, Insulin Resistance, HIV Infections, Metabolic Syndrome XArmsRosiglitazone, Recombinant human growth hormone + rosiglitazone
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. 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

5 authors at 3 institutions in 1 country.

Donald P KotlerGastrointestinal Division, Department of Medicine, St Luke's-Roosevelt Hospital Center, Columbia University College of Physicians and Surgeons, New York, NY, USA. dkotler@chpnet.org.
Qing He
Ellen S Engelson
Jeanine B Albu
Marshall J Glesby
St. Luke's-Roosevelt Hospital Center · USColumbia University · USCornell University · US

Funding

Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024996 · NCRR · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2007 to 2011
$49.6M
RESEARCH TRAININGP30DK026687 · NIDDK · ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS · PI Anthony W Ferrante, DYMPNA GALLAGHER · 1986 to 2026
$33.0M
Translational Research CoreP30DK020541 · NIDDK · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI Shuibing Chen · 2015 to 2026
$27.7M
Growth Hormone and Rosiglitazone for Visceral AdoposityR01DK065515 · NIDDK · WEILL MEDICAL COLL OF CORNELL UNIV · PI GLESBY, MARSHALL J · 2004 to 2007
$1.8M
Complications of Chronic Viral InfectionsK24AI078884 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI GLESBY, MARSHALL J · 2008 to 2012
$892k
NCATS NIH HHS UL1 TR002384NCRR NIH HHS UL1 RR024156NCRR NIH HHS UL1 RR024996NIAID NIH HHS K24 AI078884NIDDK NIH HHS P30 DK020541NIDDK NIH HHS P30 DK026687NIDDK NIH HHS R01 DK065515
6 · The paper itself

Abstract

backgroundHepatic fat is related to insulin resistance (IR) and visceral adipose tissue (VAT) in HIV+ and uninfected individuals. Growth hormone (GH) reduces VAT but increases IR. We evaluated the effects of recombinant human GH (rhGH) and rosiglitazone (Rosi) on hepatic fat in a substudy of a randomized controlled trial.

methodsHIV+ subjects with abdominal obesity and IR (QUICKI≤0.33) were randomized to rhGH 3 mg daily, Rosi 4 mg twice daily, the combination or double placebo. Hepatic fat was measured by magnetic resonance spectroscopy, visceral fat by MRI and IR by frequently sampled intravenous glucose tolerance tests at baseline and week 12.

results31 subjects were studied at both time points. Significant correlations between hepatic fat and VAT (r=0.41; P=0.02) and QUICKI (r=0.39; P<0.05) were seen at baseline. IR rose with rhGH but not Rosi. When rhGH treatment groups were combined, hepatic fat expressed as percentage change decreased significantly (P<0.05) but did not change in Rosi (P=0.71). There were no correlations between changes in hepatic fat and VAT (P=0.4) or QUICKI (P=0.6). In a substudy of 21 subjects, a trend was noticed between changes in hepatic fat and serum insulin-like growth factor-1 (IGF-1; P=0.09).

conclusionsHepatic fat correlates significantly with both VAT and IR, but changes in hepatic fat do not correlate with changes in VAT and glucose metabolism. Hepatic fat content is reduced by rhGH but Rosi has no effect. These results suggest an independent effect of GH or IGF-1 on hepatic fat. The study was registered at Clinicaltrials.gov (NCT00130286).

Indexed as

Body CompositionDouble-Blind MethodFatty LiverFemaleGrowth HormoneHIV InfectionsHumansHypoglycemic AgentsInsulin-Like Growth Factor IInsulin ResistanceIntra-Abdominal FatLiverMaleMiddle AgedRosiglitazoneThiazolidinedionesGrowth HormoneHypoglycemic AgentsInsulin-Like Growth Factor IRosiglitazoneThiazolidinediones

Identifiers

PMID25536669
PMCPMC5110034
OpenAlexW2320885151

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.