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临床试验/NCT00182975
NCT00182975已完成3 期

Is DHEA Replacement Beneficial?

National Institute on Aging (NIA)2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2002年9月1日最近更新:
适应症
相关药物

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

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)

研究者

发起方
National Institute on Aging (NIA)
申办方类型
Nih

研究点 (2)

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