This is a study in pre- and peri-menopausal women with onset of rheumatoid arthritis (RA) of less than 3 years duration, and active, inflammatory disease, that is being conducted at the NIH Clinical Center. In this investigation, we hypothesize that the excess of systemically released inflammatory cytokines in RA patients suppresses activity of the GH/IGF-1 axis, and that the combined effects of disordered endocrine-immune function contribute to changes in body composition, endocrine-metabolic and vascular functions thought predisposing to RA-related sarcopenia, osteopenia and increased cardiovascular risk. In phase I of the study, RA patients and control subjects are admitted to the Clinical Center for a 36 hour period for assessments of the GH/IGF-I axis, cytokines, body composition, endocrine- metabolic and cardiovascular functions, and quality of life. We have initiated Phase I of the study to compare baseline endocrine and inflammatory parameters in RA patients with those in healthy, age- and BMI-matched women. Should the hypotheses in Phase I be satisfied, we plan to conduct a 2nd Phase of the study, in which we shall enroll a similar group of RA patients to evaluate the above outcome measures at baseline and after six months of treatment with one of the available TNF-alpha receptor antagonists, both in the absence and presence of DHEA or other CAM intervention (e.g. meditation). To date, 7 RA patients and 10 matched control subjects have been evaluated; and enrollment for Phase I has been ended. Hormone, cytokine, body composition and other data are being tabulated and analysed in anticipation of manuscript preparation.
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