Skip to main content
Clinical Trials/NCT02765945
NCT02765945
Completed
Not Applicable

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 site in 1 country43 target enrollmentStarted: December 1996Last updated:
ConditionsOsteoporosis

Overview

Phase
Not Applicable
Status
Completed
Enrollment
43
Locations
1
Primary Endpoint
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)

Overview

Brief Summary

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.

Detailed Description

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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Normal exercise treadmill test

Exclusion Criteria

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

Outcomes

Primary Outcomes

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)

Time Frame: 6 months

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

Time Frame: 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

Time Frame: 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

Time Frame: 6 months

Immunophenotyping of blood mononuclear cells by FACScan flow cytometer

Evidence of altered serum factors of bone homeostasis

Time Frame: 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

Time Frame: 6 months

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

John Kelly Smith

Emeritus Professor of Medicine

East Tennessee State University

Study Sites (1)

Loading locations...

Similar Trials