NCT00474279

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 1998

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
5.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2007

Completed
Last Updated

May 16, 2007

Status Verified

May 1, 2007

First QC Date

May 15, 2007

Last Update Submit

May 15, 2007

Conditions

Aging

Keywords

Growth hormone secretagogueBody compositionFunctional abilityAgingSarcopenia

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (13)

  • 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

  • +8 more secondary outcomes

Interventions

Orally active growth hormone secretagogue (MK-677)DRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women  60 years of age, with a body mass index of \< 35 kg/m2.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • 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. doi: 10.1210/jcem.81.12.8954023.

    PMID: 8954023BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Interventions

ibutamoren mesylate

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Michael O. Thorner, MBBS, DSc,

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2007

First Posted

May 16, 2007

Study Start

July 1, 1998

Study Completion

June 1, 2004

Last Updated

May 16, 2007

Record last verified: 2007-05

Locations

US(1)