Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly

NCT ID: NCT00807365

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-17
• Study Completion Date: 2010-04-29

Brief Summary

The purpose of the study is to evaluate the effect of a naturally occurring hormone, called Growth Hormone Releasing Hormone (GHRH), on the muscle, bone and fat tissues of the body. GHRH stimulates the production of growth hormone (GH), which regulates the build up of many tissues in the body, including muscles and bones. Many elderly people have low levels of GH. The overall goal of this research is to determine the effectiveness of GHRH to raise levels of GH and improve these body tissues. The purpose of the tests is to measure how the body handles sugar, fat, and proteins. GH can affect your body's use of sugar, fat and proteins.

Detailed Description

Growth hormone (GH) is a major anabolic hormone that exerts important stimulatory effects on protein synthesis. Many of the peripheral tissue effects of GH are mediated by insulin-like growth factor I (IGF-I), produced systemically by the liver or locally in tissues in response to GH stimulation. IGF-I in turn regulates GH secretion by negative feedback mechanisms at the pituitary gland. Several investigators have shown that aging is associated with a decrease in spontaneous GH secretion and IGF-I levels. GH levels decline by 14% for each decade after puberty, and, in healthy 59-98 year old men, IGF-I levels below the 2.5 percentile of younger men are present in 85%. Reduction of GH release in aging is thought to be associated with an increase in somatostatin tone, decrease in hypothalamic GHRH output, and diminished response to GHRH. The fact that aging is accompanied by a decrease in protein synthesis leading to a loss of lean body mass (LBM) and a gain in body fat suggests that a decrease in GH secretion may contribute to these changes. It has been hypothesized that restoration of GH level in the elderly to the levels observed in younger individuals may lead to improvements in body composition.

Conditions

Elderly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GHRH

Growth Hormone-Releasing Hormone

Group Type: EXPERIMENTAL

GHRH

Intervention Type: DRUG

GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, \& 5:00 AM for 6 months.

Interventions

GHRH

GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, \& 5:00 AM for 6 months.

Intervention Type: DRUG

Other Intervention Names

Growth Hormone-Releasing Hormone

Eligibility Criteria

Inclusion Criteria

• Documentation of low GH levels as assessed by a fasting IGF-1 level <135ng/ml.
• Volunteers whose BMI is above normal range and below extreme obesity (BMI 25-40 kg/m2).

Exclusion Criteria

• Diabetes.
• Known coronary artery disease.
• Liver, peptic or inflammatory bowel disease. Renal or hematologic disease.
• Hematocrit <30% or >50%.
• Clinically significant prostate hypertrophy.
• Elevated Prostate specific antigen (PSA) (4ng/ml).
• Prostate & breast cancer.
• History of malignancy <5 years other than basal cell of the skin.
• Chronic pulmonary disease or other systemic disorders.
• Use of certain drugs (such as thiazide diuretics, beta-blockers, steroids (except for replacement doses), coumadin, and or androgen supplements).
• Peanut allergy.
• Gross physical impairment.
• Sleep apnea.
• Uncontrolled hypertension(blood pressure >160/95 and or requiring more than two antihypertensive medications).
• A clinically worrisome mammogram in women.
• Exercise training (>2x/wk for 20 min at a level that produces sweating) in the last 6 months.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dariush Elahi, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Kenneth L. Minaker, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2002P-001781

Identifier Type: -

Identifier Source: secondary_id

P01-AG0059-21

Identifier Type: -

Identifier Source: secondary_id

NA_00005793

Identifier Type: -

Identifier Source: org_study_id