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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014