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

Sponsor:	University of Virginia
Information provided by:	University of Virginia
ClinicalTrials.gov Identifier:	NCT00474279

Purpose

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.

Condition	Intervention	Phase
Aging	Drug: Orally active growth hormone secretagogue (MK-677)	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults

Resource links provided by NLM:

Drug Information available for: Somatropin Ibutamoren mesylate Somatotropin

U.S. FDA Resources

Further study details as provided by University of Virginia:

Primary Outcome Measures:

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:

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.

Estimated Enrollment:	72
Study Start Date:	July 1998
Study Completion Date:	June 2004

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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474279

Locations

United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

University of Virginia

Investigators

Principal Investigator:

Michael O. Thorner, MBBS, DSc,

University of Virginia

More Information

Publications:

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.

Study ID Numbers:	HIC #7444, NIH RO1 DK32632
Study First Received:	May 15, 2007
Last Updated:	May 15, 2007
ClinicalTrials.gov Identifier:	NCT00474279 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Virginia:

Growth hormone secretagogue
Body composition
Functional ability
Aging
Sarcopenia

Additional relevant MeSH terms:

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009