drugset / Trial / NCT00183040
HORMA: Hormonal Regulators of Muscle and Metabolism in Aging
RandomizedFactorialDouble-blindTreatment
Summary
The purpose of this study is to determine the relationship of deficiencies in testosterone and growth hormone to loss of muscle mass (sarcopenia) and functional impairment during aging and whether there is an interaction of these two hormone systems in maintaining normal skeletal muscle mass and physical function.
Timeline
- Start
- 2002-09
- Primary completion
- 2007-02
- Completion
- 2007-02
Publications
- Background Dutta C, Hadley EC, Lexell J. Sarcopenia and physical performance in old age: overview. Muscle Nerve Suppl. 1997;5:S5-9. No abstract available.
- Background Hasten DL, Pak-Loduca J, Obert KA, Yarasheski KE. Resistance exercise acutely increases MHC and mixed muscle protein synthesis rates in 78-84 and 23-32 yr olds. Am J Physiol Endocrinol Metab. 2000 Apr;278(4):E620-6. doi: 10.1152/ajpendo.2000.278.4.E620.
- Background Urban RJ, Bodenburg YH, Gilkison C, Foxworth J, Coggan AR, Wolfe RR, Ferrando A. Testosterone administration to elderly men increases skeletal muscle strength and protein synthesis. Am J Physiol. 1995 Nov;269(5 Pt 1):E820-6. doi: 10.1152/ajpendo.1995.269.5.E820.
- Background Ferrando AA, Sheffield-Moore M, Yeckel CW, Gilkison C, Jiang J, Achacosa A, Lieberman SA, Tipton K, Wolfe RR, Urban RJ. Testosterone administration to older men improves muscle function: molecular and physiological mechanisms. Am J Physiol Endocrinol Metab. 2002 Mar;282(3):E601-7. doi: 10.1152/ajpendo.00362.2001.
- Background Blackman MR, Sorkin JD, Munzer T, Bellantoni MF, Busby-Whitehead J, Stevens TE, Jayme J, O'Connor KG, Christmas C, Tobin JD, Stewart KJ, Cottrell E, St Clair C, Pabst KM, Harman SM. Growth hormone and sex steroid administration in healthy aged women and men: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2282-92. doi: 10.1001/jama.288.18.2282.
- Yarasheski KE, Castaneda-Sceppa C, He J, Kawakubo M, Bhasin S, Binder EF, Schroeder ET, Roubenoff R, Azen SP, Sattler FR. Whole-body and muscle protein metabolism are not affected by acute deviations from habitual protein intake in older men: the Hormonal Regulators of Muscle and Metabolism in Aging (HORMA) Study. Am J Clin Nutr. 2011 Jul;94(1):172-81. doi: 10.3945/ajcn.110.010959. Epub 2011 May 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatropin | Protein / enzyme biologic | 3 ug/kg | — |
| Subject | Somatropin | Protein / enzyme biologic | 5 ug/kg | — |
| Subject | Testosterone | Small molecule | 5 g | Topical |
| Subject | Testosterone | Small molecule | 10 g | Topical |