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

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01316731
• Other study ID #: NL33968.081.10
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: December 20, 2011
• Start date: February 2011
• Est. completion date: June 2011

Study information

• Verified date: December 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Exercise
• Gene Expression
• Muscle
• Myokine

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Division of Human Nutrition, Wageningen University	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	Dutch Diabetes Research Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	PBMC gene expression changes before and after exercise	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	No
Secondary	Routine plasma level changes before and after exercise	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	No
Secondary	Heart rate changes, baseline compared with exercise	Heart rate will be measured during the maximum work load test and the experimental exercise period.	During the intervention	No