Evidence map›Paper›PMID 34375393›Full record

Trial reportThe American journal of clinical nutrition2021

Cognitive response to testosterone replacement added to intensive lifestyle intervention in older men with obesity and hypogonadism: prespecified secondary analyses of a randomized clinical trial.

Giulia Gregori, Alessandra Celli, Yoann Barnouin, Arjun Paudyal, Reina Armamento-Villareal, Nicola Napoli, Clifford Qualls, Dennis T Villareal

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

Trial report in The American journal of clinical nutrition, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02367105 (Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
1.3field-weighted citation impact, top 19% 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.

NCT02367105 phase3completednot on this map

Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2015 to 2019Enrolled83ConditionsObesity and HypogonadismArmsTestosterone, Lifestyle Therapy, Placebo
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Testosterone replacement in men with sexual dysfunction.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Guideline
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Review
  9. Correlation between obesity and AlzheimerZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Review
  10. Article
  11. Review
  12. Testosterone, cognitive decline and dementia in ageing men.Reviews in endocrine & metabolic disorders · 2022
    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

8 authors at 3 institutions in 1 country.

Giulia GregoriCenter for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.
Alessandra CelliCenter for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.
Yoann BarnouinCenter for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.
Arjun PaudyalCenter for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.
Reina Armamento-VillarealCenter for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.
Nicola NapoliDivision of Endocrinology and Metabolism, Washington University School of Medicine, St Louis, MO, USA.
Clifford QuallsDepartment of Mathematics and Statistics, University of New Mexico School of Medicine, Albuquerque, NM, USA.
Dennis T VillarealCenter for Translational Research on Inflammatory Diseases, Michael E DeBakey VA Medical Center, Houston, TX, USA.ORCID 0000-0003-1365-7960
Michael E. DeBakey VA Medical Center · USUniversity of New Mexico · USWashington University in St. Louis · US

Funding

WU P&FP30DK020579 · NIDDK · WASHINGTON UNIVERSITY · PI Clay F. Semenkovich · 2013 to 2026
$27.1M
Testosterone Replacement to Augment Lifestyle Therapy in Obese Older VeteransI01CX000906 · VA · MICHAEL E DEBAKEY VA MEDICAL CENTER · PI VILLAREAL, DENNIS T. · 2014 to 2019
–
CSRD VA I01 CX000906NIDDK NIH HHS P30 DK020579
6 · The paper itself

Abstract

backgroundBoth obesity and hypogonadism are common in older men which could additively exacerbate age-related declines in cognitive function. However, little is known about the effects of lifestyle intervention plus testosterone replacement therapy in this population.

objectivesIn this secondary analysis of the LITROS (Lifestyle Intervention and Testosterone Replacement in Obese Seniors) trial, we examined whether testosterone replacement therapy would improve cognitive function when added to intensive lifestyle intervention in older men with obesity and hypogonadism.

methodsEighty-three older, obese hypogonadal men with frailty were randomly assigned to lifestyle therapy (weight management and exercise training) plus testosterone (LT + Test) or lifestyle therapy plus placebo (LT + Pbo) for 6 mo. For this report, the primary outcome was change in the global cognition composite z score. Secondary outcomes included changes in z score subcomponents: attention/information processing, memory, executive function, and language. Changes between groups were analyzed using mixed-model repeated-measures ANCOVAs following the intention-to-treat principle.

resultsGlobal cognition z score increased more in the LT + Test than in the LT + Pbo group (mean change: 0.49 compared with 0.21; between-group difference: -0.28; 95% CI: -0.45, -0.11; Cohen's d = 0.74). Moreover, attention/information z score and memory z score increased more in the LT + Test than in the LT + Pbo group (mean change: 0.55 compared with 0.23; between-group difference: -0.32; 95% CI: -0.55, -0.09; Cohen's d = 0.49 and mean change: 0.90 compared with 0.37; between-group difference: -0.53; 95% CI: -0.93, -0.13; Cohen's d = 1.43, respectively). Multiple regression analyses showed that changes in peak oxygen consumption, strength, total testosterone, and luteinizing hormone were independent predictors of the improvement in global cognition (R2 = 0.38; P < 0.001).

conclusionsThese findings suggest that in the high-risk population of older men with obesity and hypogonadism, testosterone replacement may improve cognitive function with lifestyle behaviors controlled via lifestyle intervention therapy.This trial was registered at clinicaltrials.gov as NCT02367105.

Indexed as

Hormone Replacement TherapyLife StyleAgedCognitionDouble-Blind MethodHumansHypogonadismMaleObesityOxygen ConsumptionTestosteroneTestosteroneadiposityagingandrogenscognitiondietexercisefrailtyobesity

Identifiers

PMID34375393
PMCPMC8588849
OpenAlexW3187163581

What Socratic holds

Textmetadata
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 Socratic graph.