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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014