Evidence map›Paper›PMID 21516030›Full record

Trial reportAIDS (London, England)2011

Effects of tesamorelin on inflammatory markers in HIV patients with excess abdominal fat: relationship with visceral adipose reduction.

Takara L Stanley, Julian Falutz, Jean-Claude Mamputu, Graziella Soulban, Diane Potvin, Steven K Grinspoon

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02975258 (Adiposity and Airway Inflammation in HIV-Associated Airway Disease), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 12% 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.

NCT02975258 completednot on this mapstarted 2015, after this paper: background citation

Adiposity and Airway Inflammation in HIV-Associated Airway Disease

TypeobservationalSponsorUniversity of PittsburghRan2015 to 2017Enrolled102ConditionsAsthma, HIV, AdiposityArmsBlood draw, Questionnaires, Spirometry, Methacholine challenge test, Quantitative CT scans
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012
    Trial
  5. HIV and antiretroviral therapy-related fat alterations.Nature reviews. Disease primers · 2020
    Review
  6. Article
  7. Review
  8. Review
  9. Effects of growth hormone-releasing hormone on visceral fat, metabolic, and cardiovascular indices in human studies.Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society · 2015
    Review
  10. Review
  11. 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

6 authors at 3 institutions in 2 countries.

Takara L StanleyProgram in Nutritional Metabolism, Massachusetts General Hospital, Boston, 02114, USA.
Julian Falutz
Jean-Claude Mamputu
Graziella Soulban
Diane Potvin
Steven K Grinspoon
Theratechnologies (Canada) · CAMassachusetts General Hospital · USMcGill University Health Centre · CA

Funding

ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Takara Leah Stanley · 1994 to 2026
$31.6M
Strategies to Improve CAD Risk In HIV DiseaseK24DK064545 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI GRINSPOON, STEVEN K. · 2003 to 2012
$1.6M
Metabolic Effects of Augmenting Pulsatile Growth Hormone Secretion in HIV-InfectiK23DK089910 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI STANLEY, TAKARA LEAH · 2010 to 2014
$795k
NIDDK NIH HHS K23 DK089910NIDDK NIH HHS K24 DK064545NIDDK NIH HHS P30 DK040561
6 · The paper itself

Abstract

objectiveTo report the effects of tesamorelin, a growth hormone-releasing hormone analogue, on inflammatory and fibrinolytic markers and to relate these effects to changes in visceral adipose tissue (VAT). DESIGN AND

methodsFour hundred and ten HIV-infected patients with abdominal adiposity were randomized to 2 mg tesamorelin (n = 273) or placebo (n = 137) subcutaneously daily for 26 weeks. Circulating plasminogen activator inhibitor-1 (PAI-1) antigen, tissue plasminogen activator (tPA) antigen, C-reactive protein (CRP), and adiponectin were assessed.

resultsAt baseline, VAT was significantly associated with PAI-1 antigen (ρ = 0.36, P < 0.001), tPA antigen (ρ = 0.29, P < 0.001), CRP (ρ = 0.18, P < 0.001), and adiponectin (ρ = -0.22, P < 0.001). Treatment with tesamorelin resulted in a significant decrease from baseline in tPA antigen (-2.2 ± 2.5 vs. -1.6 ± 2.9 ng/ml, tesamorelin vs. placebo, P < 0.05). Changes in PAI-1 antigen were not significant in the tesamorelin group compared to placebo. Among patients receiving tesamorelin, changes in inflammatory markers were associated with change in VAT (PAI-1 antigen: ρ = 0.16, P = 0.02; tPA antigen: ρ = 0.16, P = 0.02; adiponectin: ρ = -0.27, P < 0.001), and these associations remained significant when controlling for changes in insulin-like growth factor-1.

conclusionIn HIV patients with abdominal adiposity, tesamorelin may have a modest beneficial effect on adiponectin and fibrinolytic markers in association with changes in VAT. Further studies are needed to determine the clinical significance of these changes. These data further highlight the deleterious role of excessive VAT and the utility of strategies to improve VAT in this population.

Indexed as

Abdominal FatAdultAgedAnalysis of VarianceBiomarkersC-Reactive ProteinFemaleGrowth Hormone-Releasing HormoneHIV-1HIV InfectionsHumansInflammationIntra-Abdominal FatMaleMiddle AgedPlacebosBiomarkersC-Reactive ProteinGrowth Hormone-Releasing HormonePlacebosPlasminogen Activator Inhibitor 1tesamorelin

Identifiers

PMID21516030
PMCPMC3673013
OpenAlexW2027142252

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.