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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00474279
First Posted: May 16, 2007
Last Update Posted: May 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Virginia
May 15, 2007
May 16, 2007
May 16, 2007
July 1998
Not Provided
  • 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
Same as current
No Changes Posted
  • 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.
Same as current
Not Provided
Not Provided
 
Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults
Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Aging
Drug: Orally active growth hormone secretagogue (MK-677)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
June 2004
Not Provided

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
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00474279
HIC #7444
NIH RO1 DK32632
Yes
Not Provided
Not Provided
Not Provided
University of Virginia
Not Provided
Principal Investigator: Michael O. Thorner, MBBS, DSc, University of Virginia
University of Virginia
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP