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

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00474279
First received: May 15, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults

Resource links provided by NLM:


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:
ClinicalTrials.gov Identifier: NCT00474279     History of Changes
Other Study ID Numbers: HIC #7444, NIH RO1 DK32632
Study First Received: May 15, 2007
Last Updated: May 15, 2007
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:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014