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

NCT ID: NCT00474279

Last Updated: 2007-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-07-31
• Study Completion Date: 2004-06-30

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.

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.

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Orally active growth hormone secretagogue (MK-677)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Principal Investigators

Michael O. Thorner, MBBS, DSc,

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

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. doi: 10.1210/jcem.81.12.8954023.

Reference Type: BACKGROUND

PMID: 8954023 (View on PubMed)

Other Identifiers

NIH RO1 DK32632

Identifier Type: -

Identifier Source: secondary_id

HIC #7444

Identifier Type: -

Identifier Source: org_study_id