Body compositional and cardiometabolic effects of testosterone therapy in obese men with severe obstructive sleep apnoea: a randomised placebo-controlled trial
Abstract
BACKGROUND: The combination of male gender, obstructive sleep apnoea (OSA) and obesity magnifies cardiometabolic risk. There has been no systematic study evaluating whether testosterone therapy can improve cardiometabolic health in obese men with OSA by improving body composition, visceral abdominal fat and insulin sensitivity. OBJECTIVE: To assess body compositional and cardiometabolic effects of testosterone treatment in obese men with severe OSA. DESIGN: An 18-week randomised, double-blind, placebo-controlled and parallel group trial in 67 men. METHODS: Participants (age=49 ± 12 years, apnoea hypopnoea index=39.9 ± 17.7 events/h, BMI=31.3 ± 5.2 kg/m(2)) were placed on a hypocaloric diet and received i.m. injections of either 1000 mg testosterone undecanoate (n=33) or placebo (n=34) for 18 weeks. Outcomes were the changes in body composition (total muscle mass, total and abdominal fat, total body dual-energy X-ray absorptiometry and computerised tomography (CT)), weight, insulin sensitivity (homeostasis model assessment), abdominal liver fat (CT), arterial stiffness (pulse wave analysis), resting metabolic rate and respiratory quotient (indirect calorimetry) and blood lipids and metabolic syndrome from baseline to week 18. RESULTS: After 18 weeks, testosterone treatment increased insulin sensitivity (-1.14 units, 95% confidence interval (95% CI) -2.27 to -0.01, P<0.05), reduced liver fat (0.09 Hounsfield attenuation ratio, 95% CI 0.009 to 0.17, P=0.03) and increased muscle mass (1.6 kg, 95% CI 0.69 to 2.5, P=0.0009) to a greater extent than placebo. Other measures of body composition and regional adiposity as well as the number of participants with metabolic syndrome did not change. Testosterone also decreased arterial stiffness (augmentation index) by 3.2% (95% CI -6.01 to -0.46%, P=0.02) and decreased the respiratory quotient (95% CI -0.04, -0.08 to -0.001, P=0.04) after 18 weeks compared with placebo. CONCLUSION: Eighteen weeks of testosterone therapy in obese men with OSA improved several important cardiometabolic parameters but did not differentially reduce overall weight or the metabolic syndrome. Longer term studies are required.
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In an 18-week placebo-controlled RCT in obese patients with obstructive sleep apnea, the combination of TRT and lifestyle modifications improved insulin sensitivity, reduced liver fat, and increased muscle mass compared with placebo and lifestyle modifications alone.
“Similarly, an 18-week, placebocontrolled RCT in obese patients with obstructive sleep apnea demonstrated that the combination of TRT and lifestyle modifications improved insulin sensitivity, reduced liver fat, and increased muscle mass in comparison with placebo and lifestyle modifications alone (69).”
From Body weight loss reverts obesity-associated hypogonadotropic hypogonadism: a systematic review and meta-analysis (2013) · cites this paper as [69]
Substantial evidence implicates testosterone and cortisol in the development of insulin resistance.
“substantial evidence implicate testosterone and cortisol in the development of insulin resistance.”
From Sleep, testosterone and cortisol balance, and ageing men (2022) · cites this paper as [87]
Testosterone treatment improves insulin sensitivity in men at risk for type 2 diabetes mellitus.
“Randomized controlled trials show that testosterone treatment improves insulin sensitivity in men at risk for type 2 diabetes mellitus (T2DM) [86, 87]”
From Sleep, testosterone and cortisol balance, and ageing men (2022) · cites this paper as [87]
In men with OSA, 18 weeks of testosterone therapy reduced liver fat compared with placebo.
“reduced liver fat”
From Sleep, testosterone and cortisol balance, and ageing men (2022) · cites this paper as [87]
In men with OSA, 18 weeks of testosterone therapy improved insulin sensitivity compared with placebo.
“improved insulin sensitivity”
From Sleep, testosterone and cortisol balance, and ageing men (2022) · cites this paper as [87]
In men with OSA, 18 weeks of testosterone therapy increased muscle mass compared with placebo.
“18 weeks of testosterone therapy in men with OSA increased muscle mass”
From Sleep, testosterone and cortisol balance, and ageing men (2022) · cites this paper as [87]
In men with OSA, 18 weeks of testosterone therapy heightened sexual desire compared with placebo.
“heightened sexual desire compared with placebo therapy [87, 133].”
From Sleep, testosterone and cortisol balance, and ageing men (2022) · cites this paper as [87]
Combination of testosterone replacement therapy and lifestyle measures is superior to lifestyle measures alone in increasing insulin sensitivity, glycemic control, muscle mass and reducing liver fat.
“Only few studies to date reported that combination of TRT and LSM is superior to LSM alone in increasing insulin sensitivity, glycemic control, muscle mass and reducing liver fat (4, 5).”
From Effects of liraglutide on obesity-associated functional hypogonadism in men (2019) · cites this paper as [5]
A compelling number of clinical studies demonstrated that TRT led to improvement in glycemic control and insulin sensitivity, whereas some failed to confirm these observations.
“A compelling number of clinical studies demonstrated that TRT led to improvement in glycemic control and insulin sensitivity (4, 5, 37, 42), whereas some failed to confirm these observations (43).”
From Effects of liraglutide on obesity-associated functional hypogonadism in men (2019) · cites this paper as [5]
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Testosterone and insulin resistance in the metabolic syndrome and T2DM in men
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Risks and benefits of testosterone therapy in older men
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Male Obesity-related Secondary Hypogonadism – Pathophysiology, Clinical Implications and Management
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“Vol.:(0123456789) Keywords Androgen · Glucocorticoid · Cardiometabolic health · Circadian · Sleep disordered breathing Abbreviations CPAP Continuous positive airway pressure GnRH Gonadotropin-releasing hormone LH Luteinizing hormone NREM Non-rapid eye movement OSA Obstructive sleep apnea REM Rapid eye movement SD Stan…”
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- Authors
- Hoyos, C. M., Yee, B. J., Phillips, C. L., Machan, E. A., Grunstein, R. R., & Liu, P. Y.
- Affiliations
- The University of Sydney (AU)
- Corresponding author
- Liu, Peter Y
- Venue
- European Journal of Endocrinology
- Publisher
- Oxford University Press (OUP)
- Published
- 2012-10
- Volume
- 167
- Issue
- 4
- Pages
- 531-541
- ISSN
- 0804-4643 (ISSN-L)
- 1479-683X
- OpenAlex
- W2143044197
- Cited by
- 145
- References
- 82
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 7 · 2023: 6 · 2022: 4 · 2021: 5 · 2020: 11 · 2019: 7 · 2018: 20 · 2017: 19 · 2016: 9 · 2015: 21 · 2014: 13 · 2013: 14
- FWCI
- 12.30
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- European Journal of Endocrinology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Centre National de la Recherche Scientifique
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Physiology › Obstructive Sleep Apnea Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Keywords
- testosterone replacement therapy, testosterone undecanoate, obstructive sleep apnea, obesity, body composition, insulin sensitivity, visceral fat, liver fat, muscle mass, arterial stiffness, metabolic syndrome, cardiometabolic risk, hypocaloric diet, respiratory quotient, resting metabolic rate, serum lipids, menopause, hormone replacement therapy
- MeSH terms
- Body Composition, Double-Blind Method, Heart, Hormones, Humans, Male, Metabolism, Middle Aged, Obesity, Placebos, Prostate, Severity of Illness Index, Testosterone, Treatment Outcome, Sleep Apnea, Obstructive
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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