Camilla M Hoyos1, Roo Killick, Brendon J Yee, Ronald R Grunstein, Peter Y Liu. 1. Endocrine and Cardiometabolic Research Group, NHMRC Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.
Abstract
STUDY OBJECTIVES: High doses of short-term testosterone have been shown to acutely worsen sleep-disordered breathing in men with obstructive sleep apnoea (OSA). The effects of lower, near-conventional doses of testosterone in obese men with OSA may differ over the longer term but have not been systematically studied. We assessed sleep and breathing effects of near-conventional testosterone treatment as an adjunct to weight loss in obese men with severe OSA. DESIGN: An 18-week randomized, double-blind, placebo-controlled, parallel group trial in 67 men. INTERVENTIONS: All subjects were placed on a hypocaloric diet and then received intramuscular injections of 1000 mg testosterone undecanoate or placebo at 0, 6 and 12 weeks. MEASUREMENTS AND RESULTS:Sleep and breathing were measured by nocturnal polysomnography at 0, 7 and 18 weeks. Testosterone, compared to placebo, worsened the oxygen desaturation index (ODI) by 10·3 events/h (95%CI, 0·8-19·8 events/h; P = 0·03) and nocturnal hypoxaemia (sleep time with oxygen saturation <90%, SpO(2) T90%) by 6·1% (95%CI, 1·5-10·6; P = 0·01) at 7 weeks. Testosterone therapy did not alter ODI (4·5, -5·4 to 14·4 events/h; P = 0·36) or SpO(2) T90% at 18 weeks (2·9, -1·9-7·7%; P = 0·23) compared to placebo. The testosterone treatment effects on ODI and SpO(2) T90% were not influenced by baseline testosterone concentrations (testosterone by treatment interactions, all P > 0·35). Blood testosterone concentrations did not correlate with ODI or SpO(2) T90% (all P > 0·19). CONCLUSIONS:Testosterone therapy in obese men with severe OSA mildly worsenssleep-disordered breathing in a time-limited manner, irrespective of initial testosterone concentrations. This time-dependency was not related to testosterone concentrations. TRIAL REGISTRATION: www.anzctr.org.au Identifier: ACTRN1260-6000404527.
RCT Entities:
STUDY OBJECTIVES: High doses of short-term testosterone have been shown to acutely worsen sleep-disordered breathing in men with obstructive sleep apnoea (OSA). The effects of lower, near-conventional doses of testosterone in obesemen with OSA may differ over the longer term but have not been systematically studied. We assessed sleep and breathing effects of near-conventional testosterone treatment as an adjunct to weight loss in obesemen with severe OSA. DESIGN: An 18-week randomized, double-blind, placebo-controlled, parallel group trial in 67 men. INTERVENTIONS: All subjects were placed on a hypocaloric diet and then received intramuscular injections of 1000 mg testosterone undecanoate or placebo at 0, 6 and 12 weeks. MEASUREMENTS AND RESULTS: Sleep and breathing were measured by nocturnal polysomnography at 0, 7 and 18 weeks. Testosterone, compared to placebo, worsened the oxygen desaturation index (ODI) by 10·3 events/h (95%CI, 0·8-19·8 events/h; P = 0·03) and nocturnal hypoxaemia (sleep time with oxygen saturation <90%, SpO(2) T90%) by 6·1% (95%CI, 1·5-10·6; P = 0·01) at 7 weeks. Testosterone therapy did not alter ODI (4·5, -5·4 to 14·4 events/h; P = 0·36) or SpO(2) T90% at 18 weeks (2·9, -1·9-7·7%; P = 0·23) compared to placebo. The testosterone treatment effects on ODI and SpO(2) T90% were not influenced by baseline testosterone concentrations (testosterone by treatment interactions, all P > 0·35). Blood testosterone concentrations did not correlate with ODI or SpO(2) T90% (all P > 0·19). CONCLUSIONS:Testosterone therapy in obesemen with severe OSA mildly worsens sleep-disordered breathing in a time-limited manner, irrespective of initial testosterone concentrations. This time-dependency was not related to testosterone concentrations. TRIAL REGISTRATION: www.anzctr.org.au Identifier: ACTRN1260-6000404527.
Authors: Monique S Tanna; Arthur Schwartzbard; Jeffery S Berger; Joseph Alukal; Howard Weintraub Journal: Curr Atheroscler Rep Date: 2015-03 Impact factor: 5.113
Authors: Andrea Salonia; Giulia Rastrelli; Geoffrey Hackett; Stephanie B Seminara; Ilpo T Huhtaniemi; Rodolfo A Rey; Wayne J G Hellstrom; Mark R Palmert; Giovanni Corona; Gert R Dohle; Mohit Khera; Yee-Ming Chan; Mario Maggi Journal: Nat Rev Dis Primers Date: 2019-05-30 Impact factor: 52.329