Clinical trial NCT00807365: Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly
Official title: Six Month Treatment of GHRH in the Elderly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Elderly
Keywords: Growth Hormone-Releasing Hormone
Growth Hormone Insufficiency
Aging
Growth Hormone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2008-12-11
Enrollment: 5
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Lean Body Mas
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Johns Hopkins University
name: Dariush Elahi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Kenneth L. Minaker, MD
role: PRINCIPAL_INVESTIGATOR
References: