MyoGene: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
1 other identifier
interventional
12
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
March 10, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedDecember 21, 2011
December 1, 2011
4 months
March 10, 2011
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
EXPERIMENTALInterventions
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.
Eligibility Criteria
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
- Wageningen Universitylead
- Dutch Diabetes Research Foundationcollaborator
Study Sites (1)
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, 6703 HA, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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