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

Aging Clinical Trial

— MOT089  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474279
• Other study ID #: HIC #7444
• Secondary ID: NIH RO1 DK32632
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 15, 2007
• Last updated: May 15, 2007
• Start date: July 1998
• Est. completion date: June 2004

Study information

• Verified date: May 2007
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

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

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At 12 months: 24-hour mean growth hormone concentrations
Primary	Insulin-like growth factor-I concentrations
Primary	Body weight and fat mass, specifically abdominal visceral fat
Primary	Fat-free mass
Primary	Safety determined by routine laboratory tests at 1 to 3 month intervals, yearly pap smears and mammograms
Secondary	at 12 months: Growth hormone secretory dynamics
Secondary	Isokinetic muscle strength (knee and shoulder)
Secondary	Thigh muscle cross-sectional area
Secondary	Function tests (timed walks, stair climb, chair rise)
Secondary	Quality of life assessments
Secondary	Insulin sensitivity
Secondary	Lipid profile
Secondary	Resting metabolic rate
Secondary	Aerobic exercise capacity
Secondary	Exploratory outcomes:
Secondary	effects of gender and HRT on primary outcomes
Secondary	effects of treatment in year 2: Year 2 outcomes include effects of continuation on MK-677, or crossover to placebo, placebo to MK-677
Secondary	bone mineral density at end of year 2.