Investigation of Sermorelin as a Clinical Intervention in Aging

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Consistent with its primary goal to promote the ethical practice of Age-Management Medicine, the Society for Applied Research in Aging is pleased to sponsor an investigational protocol testing the efficacy and safety of Sermorelin acetate, an FDA approved molecule. Sermorelin is a 29 amino acid analog of the naturally occurring, 44 amino acid neurohormone, Growth Hormone Releasing Hormone. Accordingly, Sermorelin is also known as Growth Hormone Releasing Hormone/Factor1-29 or GRF1-29.

Consistent with its primary goal to promote the ethical practice of Age-Management Medicine, the Society for Applied Research in Aging is pleased to sponsor an investigational protocol testing the efficacy and safety of Sermorelin acetate, an FDA approved molecule. Sermorelin is a 29 amino acid analog of the naturally occurring, 44 amino acid neurohormone, Growth Hormone Releasing Hormone. Accordingly, Sermorelin is also known as Growth Hormone Releasing Hormone/Factor1-29 or GRF1-29.

This preliminary study will last 90 days and is designed to gather reliable data on dosage, metabolic responses and possible adverse effects of Sermorelin in healthy subjects over the age of forty years. Some of the specific study objectives are as follows:

  • Define the Minimally Effective Dose (MED) of Sermorelin capable of causing a statistically significant increase in IGF-1, a marker of growth hormone action.
  • Determine and define gender differences, if any, in the MED.
  • Determine the effect of Sermorelin dosage on serum IGF-1 equilibrium point, the level at which increased doses of Sermorelin no longer produce significant increases in IGF-1 levels.
  • Determine effects of BMI and waist /hip ratio on efficacy of Sermorelin;
  • Compare and contrast the effects of different Sermorelin dosages on pituitary reserve of endogenous Somatrophin (human growth hormone; hGH). Pituitary reserve is a measure of pituitary hGH content not the number of cells that produce it. With aging they become inactive.
  • Characterize the metabolic effects of Sermorelin by performing a variety of lab tests including lipid profiles, thyroid panels, IGF binding proteins, CBC, sex hormones, etc.;
  • Evaluate the effects of Sermorelin on markers of potential adverse events such as fasting glucose, cortisol, insulin, prostate specific antigen (PSA), prolactin, etc.;
  • Collect subjective data on quality of life (QOL), libido, cognition, emotions, stress, physical condition, mood scales, etc.; and
  • Examine before and after photographs/videos to determine if treatment has any effect on physical appearance such as skin quality, body shape, muscularity, etc..

The principal investigator for this study is Karlis Ullis, M.D. Co-investigators include L. Stephen Coles, M.D., Ph.D. and Richard F. Walker, Ph.D., R.Ph. In an effort to gather the greatest amount of data possible so as to make the most reliable predictions about Sermorelin as a clinical intervention in aging, medical practitioners willing to comply with the study guidelines are invited to join it as co-investigators. At conclusion of the investigation, data will be complied into a manuscript and submitted for publication in an appropriate, peer-reviewed, MedLine-referenced professional journal.

After these baseline data have been collected and evaluated, subsequent studies will be initiated to determine effects, if any, of Sermorelin administration on performance of physical and mental tasks.

About the Society for Applied Research in Aging (SARA) http://www.ageresearchsociety.com:
SARA offers health practitioners, membership in a professional organization designed to support, complement and enhance their practice of integrative medicine. Specifically, the goals of the organization are to provide information through various channels for maintaining health, managing functional decline during senescence and preventing or delaying the onset of intrinsic diseases of aging. The Society sponsors educational events during which current and novel subjects of interest to members will be presented and discussed by experts in the field. Instruction on how to design treatment programs and studies to better understand the value of various interventions will be provided and continuing professional education credits will be awarded through colleges of medicine and other approved sources. Members will also receive as part of their membership benefits, subscription to the Society's official journal, Clinical Interventions in Aging (http://www.dovepress.com) as well as the opportunity to publish therein, outcomes data of their personal studies, new techniques and methods of treatment, clinical observations, letters, comments and so forth.

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Richard F. Walker, Ph.D., R.Ph
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