Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults
- Conditions
- Aging
- Registration Number
- NCT00474279
- Lead Sponsor
- University of Virginia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- Healthy men and women 60 years of age, with a body mass index of < 35 kg/m2.
- Medication known to affect GH secretion, other than estrogen replacement therapy
- Coronary artery disease,
- Congestive heart failure,
- Peripheral vascular disease,
- Diabetes mellitus (requiring insulin or an oral hypoglycemic agent),
- Significant hypertension (BP >180 systolic or >100 diastolic at rest);
- Renal, hepatic, pulmonary disease;
- Untreated hypothyroidism, untreated hyperthyroidism;
- History of seizure disorder;
- History of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis).
- Hematocrit < 40%, men, < 36%, women
- History of daily tobacco use within past 3 months
- Chronic alcohol abuse
- Strenuous exercise for average of more than 60 min/day
- Investigational drug within past 6 weeks
- Psychiatric history, especially anorexia nervosa
- Transmeridian travel within 2 weeks prior to or during study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method at 12 months: Growth hormone secretory dynamics Isokinetic muscle strength (knee and shoulder) Thigh muscle cross-sectional area 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.
Trial Locations
- Locations (1)
University of Virginia
🇺🇸Charlottesville, Virginia, United States