MyoGene: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle

Sponsor

Wageningen University (Other)

Overall Status

Completed

CT.gov ID

NCT01316731

Collaborator

Dutch Diabetes Research Foundation (Other)

Enrollment

Location

Arm

3.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise Muscle Gene Expression Myokine	Other: Single legged exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise	Other: Single legged 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.

Arm

Intervention/Treatment

Experimental: Exercise

Other: Single legged 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.

Outcome Measures

Primary Outcome Measures

Gene expression changes in skeletal muscle from baseline to after exercise [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.
Changes in plasma levels of selected proteins [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)

Secondary Outcome Measures

PBMC gene expression changes before and after exercise [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.
Routine plasma level changes before and after exercise [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.
Heart rate changes, baseline compared with exercise [During the intervention]
Heart rate will be measured during the maximum work load test and the experimental exercise period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Human Nutrition, Wageningen University	Wageningen	Gelderland	Netherlands	6703 HA

Sponsors and Collaborators

Wageningen University
Dutch Diabetes Research Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wageningen University

ClinicalTrials.gov Identifier:

NCT01316731

Other Study ID Numbers:

NL33968.081.10

First Posted:

Mar 16, 2011

Last Update Posted:

Dec 21, 2011

Last Verified:

Dec 1, 2011

Study Results

No Results Posted as of Dec 21, 2011