Testosterone Replacement Therapy added to Intensive Lifestyle Intervention in Older Men with Obesity and Hypogonadism.

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Obesity and hypogonadism additively contribute to frailty in older men; however, appropriate treatment remains controversial.Determine whether testosterone replacement augments the effect of lifestyle therapy on physical function in older men with obesity and hypogonadism.Randomized, double-blind, placebo-controlled trial.VA Medical Center.Eight-three older (age≥65 years) men with obesity (BMI≥30 kg/m 2) and persistently low AM testosterone (<10.4 nmol/L) associated with frailty.Participants were randomized to lifestyle therapy (weight management and exercise training) plus either testosterone (LT+Test) or placebo (LT+Pbo) for six months.Primary outcome was change in Physical Performance Test (PPT) score. Secondary outcomes included other frailty measures, body composition, BMD, physical functions, hematocrit, PSA, and sex hormones.PPT score increased similarly in LT+Test and LT+Pbo group (17% vs. 16%; P=.58). VO2peak increased more in LT+Test than LT+Pbo (23% vs. 16%; P=.03). Despite similar -9% weight loss, lean body mass and thigh muscle volume decreased less in LT+Test than LT+Pbo (-2% vs. -3 %; P=.01 and -2% vs -4%; P=04). Hip BMD was preserved in LT+Test compared with LT+Pbo (0.5% vs. -1.1%; P=.003). Strength increased similarly in LT+Test and LT+Pbo (23% vs. 22%; P=.94). Hematocrit but not PSA increased more in LT+Test than LT+Pbo (5% vs 1%; P

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