Grace Huang1, Thomas Travison1,2, Marcello Maggio3, Robert R Edwards4, Shehzad Basaria1. 1. The Research Program in Men's Health: Aging and Metabolism, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. 2. Institute for Aging Research, Hebrew Senior Life, Boston, MA, USA. 3. Department of Clinical and Experimental Medicine, University of Parma, Parma, Italy. 4. Department of Anesthesiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Abstract
OBJECTIVE: Symptomatic androgen deficiency is common in patients taking opioid analgesics, and testosterone replacement in these men improves libido, quality of life and body composition. However, the effects of testosterone replacement on metabolic and inflammatory markers in this setting have not been evaluated. This is important as opiate use itself has been associated with metabolic abnormalities. The objective of this investigation was to determine the effects of testosterone administration on metabolic and inflammatory markers in adult men with opioid-induced androgen deficiency. METHODS:Sixty-four nondiabetic men aged 18 to 64 years usingopioid analgesicsfor chronic noncancer pain with total testosterone levels <12 nmol/l were randomized to 14 weeks of transdermal testosterone gel or placebo gel daily. Total testosterone levels were measured by liquid chromatography mass spectrometry, and free testosterone was calculated using the law-of-mass-action equation. Metabolic parameters, inflammatory markers and oral glucose tolerance test (OGTT) were evaluated at baseline and 14 weeks. RESULTS: Baseline characteristics were similar between the two groups. Testosterone concentrations increased from 7·7 ± 3·0 to 27 ± 19 nmol/l in the testosterone group, but did not meaningfully change in placebo group. Mean changes in metabolic and inflammatory markers during intervention did not differ significantly between groups and were not related to changes in on-treatment serum testosterone concentrations. Glucose and insulin response to the 75 g OGTT also did not differ between groups. CONCLUSION: In this 14-week trial, testosterone administration in men with opioid-induced androgen deficiency was not associated with worsening of metabolic and inflammatory markers.
RCT Entities:
OBJECTIVE: Symptomatic androgen deficiency is common in patients taking opioid analgesics, and testosterone replacement in these men improves libido, quality of life and body composition. However, the effects of testosterone replacement on metabolic and inflammatory markers in this setting have not been evaluated. This is important as opiate use itself has been associated with metabolic abnormalities. The objective of this investigation was to determine the effects of testosterone administration on metabolic and inflammatory markers in adult men with opioid-induced androgen deficiency. METHODS: Sixty-four nondiabetic men aged 18 to 64 years using opioid analgesics for chronic noncancer pain with total testosterone levels <12 nmol/l were randomized to 14 weeks of transdermal testosterone gel or placebo gel daily. Total testosterone levels were measured by liquid chromatography mass spectrometry, and free testosterone was calculated using the law-of-mass-action equation. Metabolic parameters, inflammatory markers and oral glucose tolerance test (OGTT) were evaluated at baseline and 14 weeks. RESULTS: Baseline characteristics were similar between the two groups. Testosterone concentrations increased from 7·7 ± 3·0 to 27 ± 19 nmol/l in the testosterone group, but did not meaningfully change in placebo group. Mean changes in metabolic and inflammatory markers during intervention did not differ significantly between groups and were not related to changes in on-treatment serum testosterone concentrations. Glucose and insulin response to the 75 g OGTT also did not differ between groups. CONCLUSION: In this 14-week trial, testosterone administration in men with opioid-induced androgen deficiency was not associated with worsening of metabolic and inflammatory markers.
Authors: Katya B Rubinow; Jing H Chao; Derek Hagman; Mario Kratz; Brian Van Yserloo; Nilesh W Gaikwad; John K Amory; Stephanie T Page Journal: Am J Physiol Endocrinol Metab Date: 2017-07-11 Impact factor: 4.310