## Protocol Section
### Identification Module
**NCT ID:** NCT00474279

**Acronym:** MOT089

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

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

#### Organization Study ID Info
**ID:** HIC #7444
#### Organization
**Class:** OTHER
**Full Name:** University of Virginia
#### Secondary ID Infos
**ID:** NIH RO1 DK32632
### Status Module
#### Completion Date
**Date:** 2004-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2007-05-16

**Type:** ESTIMATED

**Last Update Submit Date:** 2007-05-15

**Overall Status:** COMPLETED

#### Start Date
**Date:** 1998-07

**Status Verified Date:** 2007-05

#### Study First Post Date
**Date:** 2007-05-16
**Type:** ESTIMATED
**Study First Submit Date:** 2007-05-15
**Study First Submit QC Date:** 2007-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Virginia

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Aging

**Keywords:**

- Growth hormone secretagogue

- Body composition

- Functional ability

- Aging

- Sarcopenia

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 72

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Orally active growth hormone secretagogue (MK-677)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** At 12 months: 24-hour mean growth hormone concentrations

**Measure:** Insulin-like growth factor-I concentrations

**Measure:** Body weight and fat mass, specifically abdominal visceral fat

**Measure:** Fat-free mass

**Measure:** Safety determined by routine laboratory tests at 1 to 3 month intervals, yearly pap smears and mammograms

#### Secondary Outcomes

**Measure:** at 12 months: Growth hormone secretory dynamics

**Measure:** Isokinetic muscle strength (knee and shoulder)

**Measure:** Thigh muscle cross-sectional area

**Measure:** Function tests (timed walks, stair climb, chair rise)

**Measure:** Quality of life assessments

**Measure:** Insulin sensitivity

**Measure:** Lipid profile

**Measure:** Resting metabolic rate

**Measure:** Aerobic exercise capacity

**Measure:** Exploratory outcomes:

**Measure:** effects of gender and HRT on primary outcomes

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

**Measure:** bone mineral density at end of year 2.

### Eligibility Module

**Eligibility 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

**Healthy Volunteers:** True

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Charlottesville

**Country:** United States

**Facility:** University of Virginia

**State:** Virginia

**Zip:** 22908

#### Overall Officials

**Official 1:**

**Affiliation:** University of Virginia

**Name:** Michael O. Thorner, MBBS, DSc,

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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:** 8954023

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M28396

- Name: Sarcopenia

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: HIGH

- As Found: Loss

- ID: M1985

- Name: Secretagogues

- Relevance: HIGH

- As Found: Dormicum

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000006728

- Term: Hormones

- ID: D000078604

- Term: Secretagogues

### Misc Info Module

- Version Holder: 2024-05-24
