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| ID | Type | Description | Link |
|---|---|---|---|
| NIH RO1 DK32632 |
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The purpose of this study is to determine whether treatment of healthy older men and women with oral MK-677 for 12 months will enhance pulsatile GH release and increase mean GH and IGF-I concentrations into the range of young adults and will have favorable effects on body composition and functional ability on older adults.
This is a two year, double-blind, placebo-controlled cross-over trial of once daily administration of MK-677, an oral GH secretagogue, to healthy older adults. During the first year, subjects will be randomized to MK-677 or placebo treatment. In each of three subgroups of subjects (men, women off and women on hormone replacement therapy), 16 subjects will receive MK-677 and 8 will receive placebo. After 1 year, the subjects who received placebo will be switched to MK-677 treatment; the subjects who received MK-677 for the first year will be randomized to either placebo or MK-677 for the second year of the study.The study will test changes in GH, IGF-I, body composition and function.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orally active growth hormone secretagogue (MK-677) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| At 12 months: 24-hour mean growth hormone concentrations | ||
| Insulin-like growth factor-I concentrations | ||
| Body weight and fat mass, specifically abdominal visceral fat | ||
| Fat-free mass | ||
| Safety determined by routine laboratory tests at 1 to 3 month intervals, yearly pap smears and mammograms |
| Measure | Description | Time Frame |
|---|---|---|
| at 12 months: Growth hormone secretory dynamics | ||
| Isokinetic muscle strength (knee and shoulder) | ||
| Thigh muscle cross-sectional area |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael O. Thorner, MBBS, DSc, | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8954023 | Background | Chapman IM, Bach MA, Van Cauter E, Farmer M, Krupa D, Taylor AM, Schilling LM, Cole KY, Skiles EH, Pezzoli SS, Hartman ML, Veldhuis JD, Gormley GJ, Thorner MO. Stimulation of the growth hormone (GH)-insulin-like growth factor I axis by daily oral administration of a GH secretogogue (MK-677) in healthy elderly subjects. J Clin Endocrinol Metab. 1996 Dec;81(12):4249-57. doi: 10.1210/jcem.81.12.8954023. |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C094817 | ibutamoren mesylate |
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| Function tests (timed walks, stair climb, chair rise) |
| Quality of life assessments |
| Insulin sensitivity |
| Lipid profile |
| Resting metabolic rate |
| Aerobic exercise capacity |
| Exploratory outcomes: |
| effects of gender and HRT on primary outcomes |
| effects of treatment in year 2: Year 2 outcomes include effects of continuation on MK-677, or crossover to placebo, placebo to MK-677 |
| bone mineral density at end of year 2. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |