Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults

University of Virginia72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Aging

Interventions

Orally active growth hormone secretagogue (MK-677)DRUG

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy men and women  60 years of age, with a body mass index of \< 35 kg/m2. Exclusion Criteria: * 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

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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