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临床试验/NCT02765945
NCT02765945已完成不适用

The Effect of Long-term Exercise on the Production of Osteoclastogenic and Anti-osteoclastogenic Cytokines by Peripheral Blood Mononuclear Cells and on Serum Markers of Bone Metabolism

East Tennessee State University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 1996年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
Evidence of altered bone resorption and/or production as measured by measurements of serum levels of osteocalcin and degradation products of Type I collagen (C-terminal telopeptides)

研究概览

简要总结

This is the second phase of a study designed to determine the immunological effects of long-term exercise on risk factors for ischemic heart disease (phase 1) and osteoporosis (phase 2). The results indicate that six months of moderate intensity exercise reduces bone resorption and increases the secretion of anti-osteoclastogenic cytokines by peripheral blood mononuclear cells.

详细描述

In a before and after trial involving 43 healthy adults the investigators measured the effect of six months of supervised exercise on the spontaneous and phytohemagglutinin-induced production of osteoclastogenic cytokines (interleukin-1α, tumor necrosis factor-α), anti-osteoclastogenic cytokines (transforming growth factor-β, interleukins 4 and10), pleiotropic cytokines with variable effects on osteoclastogenesis (interferon-γ, interleukin-6), and T cell growth and differentiation factors (interleukins 2 and 12) by peripheral blood mononuclear cells. The investigators also measured lymphocyte phenotypes, and serum markers of bone formation (osteocalcin), bone resorption (C-terminal telopeptides of Type I collagen), and bone homeostasis (estradiol, vitamin D2, testosterone, parathyroid hormone, insulin-like growth factor).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Normal exercise treadmill test

排除标准

  • •Any medical condition that would prevent participation in a six month exercise program

结局指标

主要结局

Evidence of altered bone resorption and/or production as measured by measurements of serum levels of osteocalcin and degradation products of Type I collagen (C-terminal telopeptides)

时间窗: 6 months

Evidence of altered secretion of osteoclastogenic cytokines by peripheral blood mononuclear cells

时间窗: 6 months

secretion of IL-1 alpha, TNF-alpha, IFN-gamma by cultured peripheral blood mononuclear cells

Evidence of altered secretion of anti-osteoclastogenic cytokines by cultured peripheral blood mononuclear cells

时间窗: 6 months

secretion of IL-10, IL-4, TGF-beta, IL-6 by cultured peripheral blood mononuclear cells

Evidence of altered blood mononuclear cell phenotypes

时间窗: 6 months

Immunophenotyping of blood mononuclear cells by FACScan flow cytometer

Evidence of altered serum factors of bone homeostasis

时间窗: 6 months

Measurements of serum levels of estradiol, testosterone, PTH, IGF-1

Evidence of altered secretion of growth and differentiation factors by cultures peripheral blood mononuclear cells

时间窗: 6 months

Measurements of IL-2, IL-4, IL-12

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Kelly Smith

Emeritus Professor of Medicine

East Tennessee State University

研究点 (1)

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