Is DHEA Replacement Beneficial?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- body composition (e.g. truncal fat and visceral fat), insulin resistance and serum triglycerides, muscle mass and strength
研究概览
简要总结
The purpose of this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 65 Years 至 75 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 to 75 years old
- •Physically healthy
- •Non-smoker
- •On stable medications for at least 6 months
- •Stable body weight for the past year
排除标准
- •Serious active medical problems
- •Hormone therapy
- •Abnormal PSA (prostate specific antigen) in men
结局指标
主要结局
body composition (e.g. truncal fat and visceral fat), insulin resistance and serum triglycerides, muscle mass and strength
次要结局
- bone mineral density, arterial-endothelium dependent vasodilatation, sense of well being, RMR (Resting Metabolic Rate), TEF (Thermal Effect of Food)
