4.7 Article

Testosterone and Growth Hormone Improve Body Composition and Muscle Performance in Older Men

Journal

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Volume 94, Issue 6, Pages 1991-2001

Publisher

ENDOCRINE SOC
DOI: 10.1210/jc.2008-2338

Keywords

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Funding

  1. National Institutes of Health (NIH) [R01 AG18169]
  2. National Center for Research Resources (NCRR) General Clinical Research Center (GCRC) [M0I RR000043]
  3. University of Southern California
  4. the U. S. Department of Agriculture (USDA) ARS Cooperative Agreement [58-1950-9-001]
  5. NCRR GCRC [M01RR000054]
  6. USDA
  7. NCRR GCRC at Washington University School of Medicine [M01RR000036]
  8. Mass Spectrometry Research Resource at Washington University
  9. NIH [RR000954, DK020579, DK056341, U01AG14369, 1R01DK70534]
  10. Boston Medical Center, Boston University School of Medicine
  11. Solvay Pharmaceuticals Inc.
  12. Genentech Inc.
  13. Tap Pharmaceutical Products Inc.

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Context: Impairments in the pituitary-gonadal axis with aging are associated with loss of muscle mass and function and accumulation of upper body fat. Objectives: We tested the hypothesis that physiological supplementation with testosterone and GH together improves body composition and muscle performance in older men. Design, Setting, and Participants: One hundred twenty-two community-dwelling men 70.8 +/- 4.2 yr of age with body mass index of 27.4 +/- 3.4 kg/m(2), testosterone of 550 ng/dl or less, and IGF-I in lower adult tertile (<= 167 ng/dl) were randomized to receive transdermal testosterone (5 or 10 g/d) during a Leydig cell clamp plus GH (0, 3, or 5 mu g/kg . d) for 16 wk. Main Outcome Measures: Body composition by dual-energy x-ray absorptiometry, muscle performance, and safety tests were conducted. Results: Total lean body mass increased (1.0 +/- 1.7 to 3.0 +/- 2.2 kg) as did appendicular lean tissue (0.4 +/- 1.4 to 1.5 +/- 1.3 kg), whereas total fat mass decreased by 0.4 +/- 0.9 to 2.3 +/- 1.7 kg as did trunk fat (0.5 +/- 0.9 to 1.5 +/- 1.0 kg) across the six treatment groups and by dose levels for each parameter (P <= 0.0004 for linear trend). Composite maximum voluntary strength of upper and lower body muscles increased by 14 +/- 34 to 35 +/- 31% (P < 0.003 in the three highest dose groups) that correlated with changes in appendicular lean mass. Aerobic endurance increased in all six groups (average 96 +/- 137sec longer). Systolic and diastolic blood pressure increased similarly in each group with mean increases of 12 +/- 14 and 8 +/- 8 mm Hg, respectively. Other predictable adverse events were modest and reversible. Conclusions: Supplemental testosterone produced significant gains in total and appendicular lean mass, muscle strength, and aerobic endurance with significant reductions in whole-body and trunk fat. Outcomes appeared to be further enhanced with GH supplementation. (J Clin Endocrinol Metab 94: 1991-2001, 2009)

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