Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- At 12 months: 24-hour mean growth hormone concentrations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women 60 years of age, with a body mass index of < 35 kg/m2.
排除标准
- •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
结局指标
主要结局
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
次要结局
- Thigh muscle cross-sectional area
- at 12 months: Growth hormone secretory dynamics
- Isokinetic muscle strength (knee and shoulder)
- 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.