Evidence map›Paper›PMID 26892583›Full record

Trial reportThe journal of nutrition, health & aging2016

Effect of Lifestyle Intervention on the Hormonal Profile of Frail, Obese Older Men.

R Armamento-Villareal, L E Aguirre, C Qualls, D T Villareal

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

Trial report in The journal of nutrition, health & aging, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03490513 (Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism), which is not on this map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
7.9field-weighted citation impact, top 2% 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.

NCT03490513 phase4completednot on this mapstarted 2018, after this paper: background citation

Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism

TypeinterventionalSponsorBaylor College of MedicineRan2018 to 2025Enrolled121ConditionsHypogonadism, Hypogonadotropic, ObesityArmsanastrozole (1 mg/day), Placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 4 syntheses or guidelines pooled it, 65 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 4 institutions in 1 country.

R Armamento-VillarealDennis T. Villareal, MD, Professor of Medicine, Baylor College of Medicine, 2002 Holcombe BLVD, Houston, TX, USA, Phone: 713-794-7516, Email:dennis.villareal@bcm.edu.
L E Aguirre
C Qualls
D T Villareal
Baylor College of Medicine · USMichael E. DeBakey VA Medical Center · USNew Mexico VA Health Care System · USUniversity of New Mexico · US

Funding

Washington University Institute of Clinical and Translational Sciences (UL1)UL1RR024992 · NCRR · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2007 to 2011
$45.4M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
UNM HSC Clinical and Translational Science CenterUL1TR001449 · NCATS · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI CAMPEN, MATTHEW J, PANDHI, NANCY · 2015 to 2024
$36.9M
Washington University Nutrition Obesity Research CenterP30DK056341 · NIDDK · WASHINGTON UNIVERSITY · PI Jonathan R Brestoff · 1999 to 2026
$30.2M
WU P&FP30DK020579 · NIDDK · WASHINGTON UNIVERSITY · PI Clay F. Semenkovich · 2013 to 2026
$27.1M
TRANSGENICS COREP60DK020579 · NIDDK · WASHINGTON UNIVERSITY · PI SCHAFFER, JEAN E. · 1986 to 2012
$25.2M
University of New Mexico Clinical and Translational Science CenterUL1TR000041 · NCATS · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI LARSON, RICHARD S · 2012 to 2014
$9.8M
EXERCISE INTERVENTIONS DURING VOLUNTARY WEIGHT LOSS IN OBESE OLDER ADULTSR01AG031176 · NIA · WASHINGTON UNIVERSITY · PI VILLAREAL, DENNIS T. · 2009 to 2016
$2.3M
Weight Loss and Exercise in Frail Obese Elderly SubjectsR01AG025501 · NIA · WASHINGTON UNIVERSITY · PI VILLAREAL, DENNIS T. · 2005 to 2009
$1.7M
NCATS NIH HHS UL1 TR000041NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1 TR001449NCRR NIH HHS UL1 RR024992NCRR NIH HHS UL1-RR024992NIA NIH HHS R01 AG025501NIA NIH HHS R01-AG025501NIA NIH HHS R01 AG031176NIA NIH HHS R01 AG31176NIDDK NIH HHS DK20579NIDDK NIH HHS DK56341NIDDK NIH HHS P30 DK020579NIDDK NIH HHS P30 DK056341NIDDK NIH HHS P60 DK020579
6 · The paper itself

Abstract

objectiveObesity-associated hypogonadism is hypothesized to be due to the suppressive effect of high estradiol (from an increase in aromatase activity present in the abundant adipose tissue) on the hypothalamic-pituitary-gonadal unit resulting in low testosterone production. Although weight loss has been found to be effective in reducing estradiol and raising testosterone levels in studies of younger men, its effect in frail, obese older men is understudied. Thus, the objective of this study was to determine the effect of lifestyle intervention on hormone levels in frail, obese older men.

designRandomized controlled trial of lifestyle intervention in frail, obese older men (≥65 yo) for 1 year.

settingUniversity hospital.

methodsForty frail, obese elderly men were randomized, for a 52-week study, to any of the following treatment groups: (1) control group, (2) diet-induced weight loss group (diet group), (3) exercise training group (exercise group), and (4) diet-induced weight loss and exercise training group (diet-exercise group). The objective was to achieve a ~10 % weight loss at 6 months and maintain this weight for an additional 6 months. Physical function was assessed by the modified physical performance testing (modified PPT). Estradiol was measured by radioimmunoassay, testosterone by automated immunoassay, and sex hormone-binding globulin by enzyme-linked immunoassay.

resultsAfter 12 months of intervention, diet alone resulted in a weight loss of -10.1 ± 1.9 kg in the diet group and -9.1 ± 0.9 kg in the diet-exercise group. This resulted in a significant decrease (both p<0.05) in total estradiol compared to baseline among subjects in the diet (-2.5 ± 1.3 pg/ml) and diet-exercise group (-2.2 ± 4.0 pg/ml). Free estradiol index also significantly decreased (both p <0.05) in both the diet (-0.39 ± 0.14 pmol/nmol) and diet-exercise (-0.52 ± 0.12 pmol/nmol) group. Total testosterone significantly increased (p<0.05) in response to diet (71.0 ± 21.0 ng/dl) and diet-exercise (49.9 ± 15.5 pg/ml) resulting in values of 287.0 ± 28.1 ng/dl in the diet and 317.6 ± 33.1 ng/dl in the diet-exercise group. However, because there was a significant increase in sex hormone-binding globulin levels in both the diet and diet-exercise groups, free testosterone index and the changes in free testosterone index were not significant compared to baseline. Regardless of changes in hormonal levels, patients in the diet, exercise, and diet-exercise groups experienced significant improvements in the modified PPT from baseline.

conclusionWeight loss from lifestyle intervention resulted in significant decreases in total and free estradiol levels in frail, obese older men, but this did not result in a clinically important increase in total testosterone nor a significant increase in free testosterone. Thus, alternative forms of treatment in addition to lifestyle intervention may be necessary to improve the hormonal profile among these patients. Nevertheless, whether further improvement in hormonal profile would result in better physical performance than what can be achieved by lifestyle alone in these subjects remains uncertain.

Indexed as

Diet, ReducingFrail ElderlyLife StyleAgedEstradiolExerciseHumansMaleObesitySex Hormone-Binding GlobulinTestosteroneWeight LossEstradiolSex Hormone-Binding GlobulinTestosterone

Identifiers

PMID26892583
PMCPMC4811358
OpenAlexW2286057693

What OpenQuestion holds

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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.