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Trial · Interventional

CompletedPhase 1/2Registry data

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

Short name MOT089

NCTNCT00474279 (opens ClinicalTrials.gov in a new tab)Other idHIC #7444Other idNIH RO1 DK32632
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
72 participants
Sponsor
University of Virginia · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Jul 1998
Primary completion
Not stated
Completion
Jun 2004
First posted
16 May 2007 (estimated)
Last update posted
16 May 2007 (estimated)
Conditions
Aging

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
1998200020022004
  1. Ph 1/2

    MOT089

    NCT00474279

    Jul 1998 to Jun 2004

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

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

Arms0

The registry lists no arms for this trial.

Primary outcomes5

Outcomes the sponsor listed as primary.

  1. At 12 months: 24-hour mean growth hormone concentrations

  2. Insulin-like growth factor-I concentrations

  3. Body weight and fat mass, specifically abdominal visceral fat

  4. Fat-free mass

  5. Safety determined by routine laboratory tests at 1 to 3 month intervals, yearly pap smears and mammograms

Secondary outcomes(13)

  1. at 12 months: Growth hormone secretory dynamics

  2. Isokinetic muscle strength (knee and shoulder)

  3. Thigh muscle cross-sectional area

  4. Function tests (timed walks, stair climb, chair rise)

  5. Quality of life assessments

  6. Insulin sensitivity

  7. Lipid profile

  8. Resting metabolic rate

  9. Aerobic exercise capacity

  10. Exploratory outcomes:

  11. effects of gender and HRT on primary outcomes

  12. effects of treatment in year 2: Year 2 outcomes include effects of continuation on MK-677, or crossover to placebo, placebo to MK-677

  13. bone mineral density at end of year 2.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 1996

11 results

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.

Chapman et al. 1996The Journal of clinical endocrinology and metabolismcited by 158

PMID 8954023DOI 10.1210/jcem.81.12.8954023PUB-08954023

Rights unknown11 results
Source linkSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 60 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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