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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 10, 2011
Last Updated Date	December 20, 2011
Start Date ^ICMJE	February 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 14, 2011)	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)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01316731 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 14, 2011)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	MyoGene: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
Official Title ^ICMJE	Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Exercise Muscle Gene Expression Myokine
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: Exercise Intervention: Other: Single legged exercise
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	40 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01316731
Other Study ID Numbers ^ICMJE	NL33968.081.10
Has Data Monitoring Committee	No
Responsible Party	Wageningen University
Study Sponsor ^ICMJE	Wageningen University
Collaborators ^ICMJE	Dutch Diabetes Research Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	Wageningen University
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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