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This study evaluated testosterone replacement therapy together with lifestyle changes in older, obese men with low testosterone. It enrolled men aged 65-85 who were obese (BMI ≥30) and mildly to moderately frail; testosterone, placebo and lifestyle therapy were compared. It was a Phase 3 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: Subjects will be * older (65-85 yr) * obese (BMI 30 kg/m2 or greater) Veteran men with low testosterone (less than 300 mg/dL) as defined by the Endocrine Society * mild to moderately frail * must have stable weight (\~not less than or more than 2 kg) during the last 6 months * sedentary (regular exercise less than 1 h/week or less than 2x/week for the last 6 months) Exclusion Criteria: * Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. * Examples include, but are not limited to: * cardiopulmonary disease (e.g. recent myocardial infarction (MI), unstable angina, stroke etc) or unstable disease (e.g. CHF) * severe orthopedic/musculoskeletal or neuromuscular impairments * visual or hearing impairments * cognitive impairment (Mini Mental State Exam Score less than 24) * current use of bone active drugs * uncontrolled diabetes (i.e. fasting blood glucose more than 140 mg/dl and/or HbA1c greater than 9.5%). * Any contraindications to testosterone supplementation * history of prostate or breast cancer * history of testicular disease * untreated sleep apnea * hematocrit more than 50% * prostate-related findings of palpable nodule on exam, a serum PSA of 4.0 ng/ml or greater * International Prostate Symptom Sore more than 19 * history of venous thromboembolism * Osteoporosis or a BMD T-score of -2.5 in the lumbar spine or total hip as well as those patients with a history of osteoporosis-related fracture (spine, hip, or wrist)