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

This study has been completed.
Sponsor:
Collaborator:
Dutch Diabetes Research Foundation
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01316731
First received: March 10, 2011
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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 Intervention
Exercise
Muscle
Gene Expression
Myokine
Other: Single legged exercise

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Gene expression changes in skeletal muscle from baseline to after exercise [ Time Frame: T = 0 and T =1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: T = 0, T =1 and T = 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: T = 0, T = 1 and T =3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: T = 0, 1 and 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: During the intervention ] [ Designated as safety issue: No ]
    Heart rate will be measured during the maximum work load test and the experimental exercise period.


Enrollment: 12
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316731

Locations
Netherlands
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, Netherlands, 6703 HA
Sponsors and Collaborators
Wageningen University
Dutch Diabetes Research Foundation
  More Information

No publications provided

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01316731     History of Changes
Other Study ID Numbers: NL33968.081.10
Study First Received: March 10, 2011
Last Updated: December 20, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

ClinicalTrials.gov processed this record on April 17, 2014