Aging Clinical Trial
Official title:
Is DHEA Replacement Beneficial?
The purpose of this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects.
DHEA and DHEA sulfate (DHEAS) plasma concentrations peak at about 20 years of age and
decline rapidly and markedly after age 25 yr. DHEA is a PPAR-alpha activator. PPAR-alpha
plays major roles in regulating lipid metabolism and controlling inflammation. DHEA also
appears to have anabolic effects on muscle and bone. The study is designed to determine the
effects of 12 months of DHEA replacement in 65-75 year old women and men on (a) truncal and
visceral fat, (b) insulin resistance and serum triglycerides, (c) muscle mass and strength,
(d) bone mineral density, (e) chronic inflammation, (f) arterial-endothelium-dependent
vasodilation, and (g) sense of well being.
The specific aims of this study are to test the hypotheses that 12 months of DHEA
replacement will (a) Result in significant decreases in truncal and visceral fat by shifting
metabolism to fat oxidation and increasing energy wastage; (b) Decrease insulin resistance
and decrease serum triglycerides; (c) Increase muscle mass and strength, by decreasing
catabolic stimuli and increasing anabolic stimuli; (d) Increase bone mineral density by
increasing anabolic stimuli and decreasing catabolic stimuli; (e) Reduce chronic
inflammation and decrease pro-inflammatory cytokine production by peripheral blood
mononuclear cells; (f) Improve arterial endothelium dependent vasodilation; and (g) Improve
general sense of well being.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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