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

March 16, 2017 updated by: Johns Hopkins University

Six Month Treatment of GHRH in the Elderly

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Growth Hormone-Releasing Hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Lean Body Mas
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Massachusetts General Hospital

Investigators

  • Principal Investigator: Kenneth L. Minaker, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 17, 2007

Primary Completion (ACTUAL)

April 29, 2010

Study Completion (ACTUAL)

April 29, 2010

Study Registration Dates

First Submitted

December 10, 2008

First Submitted That Met QC Criteria

December 10, 2008

First Posted (ESTIMATE)

December 11, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00005793
  • 2002P-001781
  • P01-AG0059-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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