- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01316731
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
-
Wageningen, Gelderland, Netherlands, 6703 HA
- Division of Human Nutrition, Wageningen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 40-60 years
- Male gender
- BMI < 30 kg/m2
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Exercise
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gene expression changes in skeletal muscle from baseline to after exercise
Time Frame: T = 0 and T =1
|
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
Time Frame: T = 0, T =1 and T = 3
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PBMC gene expression changes before and after exercise
Time Frame: T = 0, T = 1 and T =3
|
Gene expression changes in the blood will be assessed using whole genome Affymetrix microarrays for the samples at T = 0, 1 and 3.
|
T = 0, T = 1 and T =3
|
|
Routine plasma level changes before and after exercise
Time Frame: T = 0, 1 and 3
|
At all three time point (T = 0, 1 and 3) plasma levels of glucose, insulin, fatty acids, triglycerides, cortisol, adrenalin and lactate will be determined.
|
T = 0, 1 and 3
|
|
Heart rate changes, baseline compared with exercise
Time Frame: During the intervention
|
Heart rate will be measured during the maximum work load test and the experimental exercise period.
|
During the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NL33968.081.10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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