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

This study has been terminated.
(PI left JHU)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807365
First Posted: December 11, 2008
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Johns Hopkins University
  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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Change in Lean Body Mas [ Time Frame: 2 years ]

Enrollment: 5
Actual Study Start Date: December 17, 2007
Study Completion Date: April 29, 2010
Primary Completion Date: April 29, 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 Post Meridian (PM), 1:00 Ante Meridian (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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00807365     History of Changes
Other Study ID Numbers: NA_00005793
2002P-001781
P01-AG0059-21
First Submitted: December 10, 2008
First Posted: December 11, 2008
Results First Submitted: March 16, 2017
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017
Last Verified: March 2017

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