NCT01316731

Brief Summary

Rationale: Proteins released from muscle during and shortly after exercise, often referred to as myokines, may be central to our understanding of the cross-talk during and after exercise between skeletal muscles and other organs, in particular the liver. So far only a few myokines are identified (e.g. IL-6, IL-8, IL-15, TNF-alpha). Taking into account the role of these several known myokines in developing insulin resistance, revealing new putative myokines might provide valuable information and a direction for future research on the pathogenesis and treatment of type 2 diabetes mellitus. Objective: The objective of the present study is to identify novel myokines, expression of which is altered in skeletal muscle after a single bout of exercise. Study design: experimental study. Study population: Ten healthy, male subjects between 40 and 60 years of age and BMI \< 30 kg/m2, will participate in this study. Intervention: A single exercise bout that consists of one hour one-legged cycling on a adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as control for the exercising leg. Main study outcomes: Main study outcomes include upregulation of genes in skeletal muscle after exercise (with a focus on genes encoding myokines) and changes of blood plasma levels of selected proteins after exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 21, 2011

Status Verified

December 1, 2011

Enrollment Period

4 months

First QC Date

March 10, 2011

Last Update Submit

December 20, 2011

Conditions

Outcome Measures

Primary Outcomes (2)

  • Gene expression changes in skeletal muscle from baseline to after exercise

    Gene expression is measured using whole genome Affymatrix microarrays Muscle tissue will be collected at time points T = 0 (before exercise) and T = 1 (directly after exercise). Special focus is on the changes in genes coding for myokines. Up to 5 genes will be selected for follow-up analysis.

    T = 0 and T =1

  • Changes in plasma levels of selected proteins

    Selected proteins will be analyzed by ELISA assays or western blot analysis, depending on ELISA availability at T = 0, T = 1 and T = 3 (2 hours post-exercise). The selection of the proteins is based on significance, the robustness of induction (\>80% of subjects showing induction) and the magnitude of the induction ( mean fold change \> 2)

    T = 0, T =1 and T = 3

Secondary Outcomes (3)

  • PBMC gene expression changes before and after exercise

    T = 0, T = 1 and T =3

  • Routine plasma level changes before and after exercise

    T = 0, 1 and 3

  • Heart rate changes, baseline compared with exercise

    During the intervention

Study Arms (1)

Exercise

EXPERIMENTAL
Other: Single legged exercise

Interventions

A single exercise bout that consists of one hour one-legged cycling on a adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as control for the exercising leg.

Exercise

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 40-60 years
  • Male gender
  • BMI \< 30 kg/m2

You may not qualify if:

  • Exercising regularly (\> 2 times a week, \> 3 hour in total per week)
  • Unstable body weight (weight gain or loss \> 3 kg in the past three months)
  • Following, or have recently followed a (weight-loss) diet
  • Donated or intended to donate blood 2 months before until two months after the study
  • Medical condition that can interfere with the study outcome (i.e. cardiovascular disease, pulmonary disease)
  • Systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg
  • Use of medications known to interfere with gene expression in the muscles (i.e. statins, fenofibrate).
  • Use of antithrombotic therapy (marcoumar, sintromitis).
  • Diagnosed diabetes mellitus type 1 or 2.
  • Drugs or alcohol abuse ( \> 3 glasses of alcoholic beverages a day).
  • (Chronic) injuries of the locomotor system that can interfere with the intervention
  • Participated in another study within the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Human Nutrition, Wageningen University

Wageningen, Gelderland, 6703 HA, Netherlands

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 16, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 21, 2011

Record last verified: 2011-12

Locations