Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults (MOT089)

University of Virginia

Status and phase

Completed

Phase 2

Phase 1

Conditions

Aging

Treatments

Drug: Orally active growth hormone secretagogue (MK-677)

Study type

Interventional

Funder types

Other

Identifiers

NCT00474279

HIC #7444

NIH RO1 DK32632

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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