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

Elderly Clinical Trial

— PP2  

Official title:

Six Month Treatment of GHRH in the Elderly

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00807365
• Other study ID #: NA_00005793
• Secondary ID: 2002P-001781P01-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 10, 2008
• Last updated: March 25, 2010
• Start date: December 2007
• Est. completion date: August 2011

Study information

• Verified date: March 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Elderly

Intervention

Drug:
• GHRH
GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GHRH administration leads to an increase in lean body mass and strength, and a decrease in fat mass.		2 years	No
Secondary	Functional outcomes as assessed with activity of daily living.		2 years	No