Clinical trial NCT01316731: MyoGene: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
Official title: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Muscle
Gene Expression
Myokine
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
First posted: 2011-03-16
Enrollment: 12
Sex: MALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Gene expression changes in skeletal muscle from baseline to after exercise
timeFrame: T = 0 and T =1
measure: Changes in plasma levels of selected proteins
timeFrame: T = 0, T =1 and T = 3
Secondary outcomes:
measure: PBMC gene expression changes before and after exercise
timeFrame: T = 0, T = 1 and T =3
measure: Routine plasma level changes before and after exercise
timeFrame: T = 0, 1 and 3
measure: Heart rate changes, baseline compared with exercise
timeFrame: During the intervention
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Division of Human Nutrition, Wageningen University
state: Gelderland
Study officials:
References: