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

• ClinicalTrials.gov Identifier: NCT00474279
• Recruitment Status: Completed
• First Posted: May 16, 2007
• Last Update Posted: May 16, 2007
• Sponsor: University of Virginia
• Information provided by: University of Virginia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aging	Drug: Orally active growth hormone secretagogue (MK-677)	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults
• Study Start Date: July 1998
• Actual Study Completion Date: June 2004

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. At 12 months: 24-hour mean growth hormone concentrations
2. Insulin-like growth factor-I concentrations
3. Body weight and fat mass, specifically abdominal visceral fat
4. Fat-free mass
5. Safety determined by routine laboratory tests at 1 to 3 month intervals, yearly pap smears and mammograms

Secondary Outcome Measures :

1. at 12 months: Growth hormone secretory dynamics
2. Isokinetic muscle strength (knee and shoulder)
3. Thigh muscle cross-sectional area
4. Function tests (timed walks, stair climb, chair rise)
5. Quality of life assessments
6. Insulin sensitivity
7. Lipid profile
8. Resting metabolic rate
9. Aerobic exercise capacity
10. Exploratory outcomes:
11. effects of gender and HRT on primary outcomes
12. effects of treatment in year 2: Year 2 outcomes include effects of continuation on MK-677, or crossover to placebo, placebo to MK-677
13. bone mineral density at end of year 2.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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.

• ClinicalTrials.gov Identifier: NCT00474279
• Other Study ID Numbers: HIC #7444; NIH RO1 DK32632
• First Posted: May 16, 2007
• Last Update Posted: May 16, 2007
• Last Verified: May 2007

Keywords provided by University of Virginia:

Growth hormone secretagogue; Body composition; Functional ability; Aging; Sarcopenia

Additional relevant MeSH terms:

Hormones; Secretagogues; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs