Six Month Treatment of Growth Hormone Releasing Hormone (GHRH) in the Elderly (PP2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00807365
First received: December 10, 2008
Last updated: March 25, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Elderly
Drug: GHRH
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Six Month Treatment of GHRH in the Elderly

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • GHRH administration leads to an increase in lean body mass and strength, and a decrease in fat mass. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional outcomes as assessed with activity of daily living. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: December 2007
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GHRH
Growth Hormone-Releasing Hormone
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.
Other Name: Growth Hormone-Releasing Hormone

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

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807365

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Johns Hopkins University
Massachusetts General Hospital
Investigators
Principal Investigator: Dariush Elahi, PhD Johns Hopkins University
Principal Investigator: Kenneth L. Minaker, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Dariush Elahi, PhD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00807365     History of Changes
Other Study ID Numbers: NA_00005793, 2002P-001781, P01-AG0059-21
Study First Received: December 10, 2008
Last Updated: March 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
Growth Hormone-Releasing Hormone
Growth Hormone Insufficiency
Aging
Growth Hormone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones

Additional relevant MeSH terms:
Hormones
Growth Hormone-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014