HGH INVESTIGATIONAL STUDY



Study Title

"Accessing the Effects of growth hormone (GH) on age-related Insulin resistance, pulmonary function, cardiovascular fitness, body composition, and quality of life. "




   Purpose of Study

    This protocol is designed to provide the physician treating human growth hormone deficiency with a means to oversee patient safety and evaluate treatment outcomes. Since the publication of Dr. Rudman's study in 1990, public demand for recombinant growth hormone (rGH) to sustain health and vitality during aging has increased to the extent that many physicians began regularly dispensing it to their patients for that purpose. However, the FDA has not registered the product for that use, and its approved indications remain fairly restrictive. Physicians are permitted to use the drug for off-label indications. So an unusual situation has been created in which the off-label use of rGH for aging has seemingly become acceptable practice by consensus through empirical rather than evidence-based medicine.
        The manufacturers of rGH are enjoying significant profits from the sale of their product without being required to meet the regulatory guidelines and make the economic investments normally associated with registration for a specific indication. Consistent with this omission is a paucity of safety and efficacy data on the use of rGH in healthy individuals as a preventative medical approach to delaying and or opposing the physical and mental deterioration associated with aging. Physicians who choose to employ rGH should realize that they have a moral, ethical, and perhaps even a legal responsibility to advise their patients that the treatment they receive is off-label.
        Physicians who use the GH replacement can contribute to a better understanding of such therapy by following a protocol with defined, objective, and quantifiable outcomes, as well as with specific guidelines for ensuring patient safety. This protocol is designed as a means to oversee patient safety and evaluate treatment outcomes. In this protocol, quantifiable biomarkers for aging have been selected as outcome measures. These particular endpoints were selected because they represent maladaptive changes leading to an increased risk for morbidity and mortality, and they can be reversed, or their occurrence delayed or attenuated by GH replacement.
        It is understood by the patient from the onset that this treatment is an investigational study, and choosing to use growth hormones could contribute to a better understanding of such therapies by following a protocol with defined objectives and quantifiable outcome, as well as following specific guidelines to insure patient safety."
1 This is an approved Investigational Review Board study under the guidelines and standards of good medical practice.

1 From "Assessing Safety and Efficacy of Growth Hormone Replacement in Aging by Community Physicians", by Richard Walker PhD., "Journal of AntiAging Medicine", Vol. 5, Number 1, 2002. See References.




   Study Objectives

   This study has three objectives or endpoints which are to determine whether:
  1. Daily administration of recombinant growth hormone (rGH) will enhance insulin sensitivity in aging subjects with reduced glucose tolerance.
  2. rGH replacement will improve quantifiable biomarkers of aging: pulmonary functions, cardiovascular compliance, and grip strength in study subjects. Specifically, will rGH improve lung vital capacity, improve cardiac fitness as measured by a simple, 3 minute test of heart rate following exercise, and improve grip strength.
  3. rGH will improve the quality of life as determined by subjects self-evaluations.

        Based upon these temporal considerations, the total study is estimated to last three years.



   Cost of Service

    For most medical investigational studies, funding is derived from grants, research funding, and major pharmaceutical companies. And even though this is an investigational study, there is not enough empirical data to cost justify the research investment by these sources. To offset the costs of the patients periodic medical exams and in-office procedures, testing, and supplies required to administer the rGH are provided at no cost to the patient.

* Excerpts from "IRB Investigational Plan" by Dr. Thomas Kockinis, 2002. (The IRB is a local FDA committee which reviews medical studies.)