HORMA: Hormonal Regulators of Muscle and Metabolism in Aging
Hormonal Regulators of Muscle and Metabolism in Aging
3 other identifiers
interventional
108
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2002
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedJune 2, 2009
May 1, 2009
4.4 years
September 13, 2005
May 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
measures of fractional synthetic rates of mixed and contractile (actin and myosin heavy chain [MHC]) skeletal muscle proteins and degradation of skeletal muscle (ubiquitin, and proteasome sub-units)
analysis of local regulators of skeletal muscle synthesis (e.g. IGF-1, IGFBP4, myostatin).
Secondary Outcomes (1)
change in skeletal muscle strength, muscle mass, power and fatigability (endurance), physical performance, and markers of safety.
Interventions
Eligibility Criteria
You may qualify if:
- Men who are 65-90 years of age
- Total serum IGF-1 (insulin-like growth factor) in the lower tertile for adults (56-167 ug/dl)
- Total serum testosterone of 150-550 ng/dL
You may not qualify if:
- BMI (Body Mass Index) 35 kg/m2 or greater
- Weight instability (\>3% change in prior 3 months)
- Daily intake of total kilocalories less than or equal to 0.8X the RDA and intake of protein between 0.8 and 1.4 g/kg/day inclusive
- Acute illness in the prior 30 days
- Resistance training (wt lifting) in the past 12 months
- Vigorous aerobic sports (Competing as a Master athlete in the prior 5 years; weekly swimming, racquet ball, cycling, tennis, in preceding 12 months)
- Use of an anabolic agent (androgen, androgen precursor, rhGH, etc) in the preceding 12 months
- Use of medications that might affect amino acid metabolism (e.g. beta-adrenergic blockers, beta-agonists, Ca2+ channel blockers, corticosteroids)
- Fasting sugar greater than or equal to 126 mg/dl or diabetes requiring Rx
- History of benign intracranial hypertension
- Heart failure, active angina, or myocardial infarction in the prior 6 months or history of aortic stenosis
- Uncontrolled hypothyroidism or hyperthyroidism
- Rheumatoid arthritis, cirrhosis or active hepatitis
- History of carpal tunnel syndrome
- Prior cancer other than squamous or basal cell carcinoma of the skin
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tufts University
Boston, Massachusetts, 02111, United States
Washington University School of Medicine
St Louis, Missouri, 63108, United States
Related Publications (6)
Dutta C, Hadley EC, Lexell J. Sarcopenia and physical performance in old age: overview. Muscle Nerve Suppl. 1997;5:S5-9. No abstract available.
PMID: 9331374BACKGROUNDHasten 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.
PMID: 10751194BACKGROUNDUrban 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.
PMID: 7491931BACKGROUNDFerrando 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.
PMID: 11832363BACKGROUNDBlackman 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.
PMID: 12425705BACKGROUNDYarasheski 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.
PMID: 21543538DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fred R. Sattler, MD
Keck School of Medicine, University of Southern California
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
September 1, 2002
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
June 2, 2009
Record last verified: 2009-05