Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/16436
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dc.contributor.authorSinclair, Marie-
dc.contributor.authorGrossmann, Mathis-
dc.contributor.authorHoermann, Rudolf-
dc.contributor.authorAngus, Peter W-
dc.contributor.authorGow, Paul J-
dc.date2016-06-14-
dc.date.accessioned2016-11-21T05:43:03Z-
dc.date.available2016-11-21T05:43:03Z-
dc.date.issued2016-11-
dc.identifier.citationJournal of Hepatology 2016; 65(5): 906-913en_US
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/16436-
dc.description.abstractBACKGROUND & AIMS: Low testosterone and sarcopenia are common in men with cirrhosis and both are associated with increased mortality. Whether testosterone therapy in cirrhosis improves muscle mass and other outcomes is unknown. METHODS: We conducted a 12-month, double-blinded, placebo-controlled trial of intramuscular testosterone undecanoate in 101 men with established cirrhosis and low serum testosterone (total testosterone <12nmol/L or free testosterone <230pmol/L) in a single tertiary centre. Body composition was assessed using dual-energy X-ray absorptiometry at baseline, 6 and 12months. RESULTS: At study completion, appendicular lean mass was significant higher in testosterone-treated subjects, with a mean adjusted difference (MAD) of +1.69kg, (CI +0.40; +2.97kg, p=0.021). Secondary outcomes included a substantially higher total lean mass in the active group (MAD +4.74kg, CI +1.75; +7.74kg, p=0.008), matched by reduced fat mass (MAD -4.34kg, CI -6.65; -2.04, p<0.001). Total bone mass increased (MAD +0.08kg, CI +0.01; +0.15kg, p=0.009) as did bone mineral density at the femoral neck (MAD +0.287points, CI +0.140; +0.434, p<0.001). Haemoglobin was higher with testosterone therapy (MAD +10.2g/L, CI +1.50; +18.9g/L, p=0.041) and percentage glycosylated haemoglobin (HbA1c) lower (MAD -0.35%, CI -0.05; -0.54, p=0.028). Mortality was non-significantly lower in testosterone-treated patients (16% vs. 25.5%, p=0.352). There was no increase in adverse events in testosterone-treated subjects. CONCLUSION: Testosterone therapy in men with cirrhosis and low serum testosterone safely increases muscle mass, bone mass and haemoglobin, and reduces fat mass and HbA1c. This is the first evidence-based therapy for sarcopenia in cirrhosis and thus requires larger-scale investigation into its potential impact on mortality. LAY SUMMARY: Both low testosterone and muscle wasting are associated with increased risk of death in men with severe liver disease. Administering testosterone to men with liver disease who have low testosterone levels significantly increases their muscle mass. In addition, testosterone has non-muscle beneficial effects which may be able to increase survival in this population. CLINICAL TRIAL NUMBER: Australian New Zealand Clinical Trials Registry trial number ACTRN 12614000526673.en_US
dc.subjectCirrhosisen_US
dc.subjectLiver diseaseen_US
dc.subjectMuscleen_US
dc.subjectSarcopeniaen_US
dc.titleTestosterone therapy increases muscle mass in men with cirrhosis and low testosterone: A randomised controlled trialen_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleJournal of Hepatologyen_US
dc.identifier.affiliationThe University of Melbourne, Parkville, Victoria, Australiaen_US
dc.identifier.affiliationGastroenterology and Hepatologyen_US
dc.identifier.affiliationEndocrinologyen_US
dc.type.studyortrialRandomized Controlled Clinical Trial/Controlled Clinical Trialen_US
dc.identifier.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/27312945en_US
dc.identifier.doi10.1016/j.jhep.2016.06.007en_US
dc.type.contentTexten_US
dc.identifier.orcid0000-0001-8261-3457en_US
dc.type.austinJournal Articleen_US
local.name.researcherAngus, Peter W
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.openairetypeJournal Article-
crisitem.author.deptGastroenterology and Hepatology-
crisitem.author.deptEndocrinology-
crisitem.author.deptVictorian Liver Transplant Unit-
crisitem.author.deptGastroenterology and Hepatology-
crisitem.author.deptVictorian Liver Transplant Unit-
crisitem.author.deptGastroenterology and Hepatology-
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