Effects of an Oral GH Secretagogue (MK-677) on Body Composition and Functional Ability of Older Adults (MOT089)
May 15, 2007 updated by: University of Virginia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
72
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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At 12 months: 24-hour mean growth hormone concentrations
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Insulin-like growth factor-I concentrations
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Body weight and fat mass, specifically abdominal visceral fat
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Fat-free mass
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Safety determined by routine laboratory tests at 1 to 3 month intervals, yearly pap smears and mammograms
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Secondary Outcome Measures
Outcome Measure |
|---|
|
at 12 months: Growth hormone secretory dynamics
|
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Isokinetic muscle strength (knee and shoulder)
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Thigh muscle cross-sectional area
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Function tests (timed walks, stair climb, chair rise)
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Quality of life assessments
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Insulin sensitivity
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Lipid profile
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Resting metabolic rate
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Aerobic exercise capacity
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Exploratory outcomes:
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effects of gender and HRT on primary outcomes
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effects of treatment in year 2: Year 2 outcomes include effects of continuation on MK-677, or crossover to placebo, placebo to MK-677
|
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bone mineral density at end of year 2.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael O. Thorner, MBBS, DSc,, University of Virginia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1998
Primary Completion
December 7, 2022
Study Completion (Actual)
June 1, 2004
Study Registration Dates
First Submitted
May 15, 2007
First Submitted That Met QC Criteria
May 15, 2007
First Posted (Estimate)
May 16, 2007
Study Record Updates
Last Update Posted (Estimate)
May 16, 2007
Last Update Submitted That Met QC Criteria
May 15, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIC #7444
- NIH RO1 DK32632
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.