Growth Hormone Administration and the Human Immune System - II
This study will investigate whether growth hormone, administered in a physiological or pulsatile (pulse-like) fashion, can elicit relevant changes in the human immune system while at the same time causing either no change or even an improvement in the metabolic profiles such as insulin sensitivity.
Growth hormone (GH) may enhance the way the human immune system responds. The human body secretes GH in a pulse-like fashion throughout the day. In this study human recombinant GH will be given using a continuous infusion pump to imitate how GH is naturally secreted so that investigators can observe how the human body responds to this method versus daily injections. Specifically, investigators will look at any relevant changes in the human immune system, metabolic profile, and possible side effects.
GH will be administered via subcutaneous (below the skin) infusion pump in a pulsatile fashion compared with once-a-day bolus for 4 weeks. Participants will be wearing this infusion pump continuously for 4 weeks. This study involves two inpatient visits, two 1-day outpatient visits, and about 9-14 short outpatient visits over a 3 month period. Procedures during this study include blood draws, MRI, CT, DEXA scan, insulin clamp procedures, oral glucose tolerance tests, and urine tests
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
human recombinant growth hormone (Growth Hormone), Placebo
National Institute on Aging Clinical Research
National Institutes of Health Clinical Center (CC)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00663611
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Human Growth Hormone
A 191-amino acid polypeptide hormone secreted by the human adenohypophysis (PITUITARY GLAND, ANTERIOR), also known as GH or somatotropin. Synthetic growth hormone, termed somatropin, has replaced the natural form in therapeutic usage such as treatment of dwarfism in children with growth hormone deficiency.
A form of dwarfism caused by complete or partial GROWTH HORMONE deficiency, resulting from either the lack of GROWTH HORMONE-RELEASING FACTOR from the HYPOTHALAMUS or from the mutations in the growth hormone gene (GH1) in the PITUITARY GLAND. It is also known as Type I pituitary dwarfism. Human hypophysial dwarf is caused by a deficiency of HUMAN GROWTH HORMONE during development.
Growth Hormone-secreting Pituitary Adenoma
A pituitary tumor that secretes GROWTH HORMONE. In humans, excess HUMAN GROWTH HORMONE leads to ACROMEGALY.
An autosomal recessive disorder characterized by short stature, defective GROWTH HORMONE RECEPTOR, and failure to generate INSULIN-LIKE GROWTH FACTOR I by GROWTH HORMONE. Laron syndrome is not a form of primary pituitary dwarfism (GROWTH HORMONE DEFICIENCY DWARFISM) but the result of mutation of the human GHR gene on chromosome 5.
The condition of accelerated and excessive GROWTH in children or adolescents who are exposed to excess HUMAN GROWTH HORMONE before the closure of EPIPHYSES. It is usually caused by somatotroph hyperplasia or a GROWTH HORMONE-SECRETING PITUITARY ADENOMA. These patients are of abnormally tall stature, more than 3 standard deviations above normal mean height for age.
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