ExerciseNCT01316731
MyoGene: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
A study testing Single legged exercise in people with Exercise and Muscle, run by Wageningen University at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise, Muscle, Gene Expression
- What is being tested?
- Single legged exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2011to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 40-60 years
- Male gender
- BMI < 30 kg/m2
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Division of Human Nutrition, Wageningen University
Wageningen, Gelderland, 6703 HA
About this study
Official title: Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
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.
Read more
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.
- Conditions
- Exercise, Muscle, Gene Expression, Myokine
- Being tested
- Single legged exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single legged exerciseOther
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 group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Other: Single legged exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T = 0 and T =1
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)
Measured: T = 0, T =1 and T = 3
Secondary outcomes (3)
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.
Measured: T = 0, T = 1 and T =3
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.
Measured: T = 0, 1 and 3
Heart rate changes, baseline compared with exercise
Heart rate will be measured during the maximum work load test and the experimental exercise period.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316731
- Sponsor's protocol ID
- NL33968.081.10
- Status last verified
- Dec 2011
- First submitted
- 10 Mar 2011
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Exercise on (Myokine) Gene Expression in Human Skeletal Muscle
- ClinicalTrials.gov ID
- NCT01316731
- Acronym / sponsor ID
- NL33968.081.10
- Conditions
- Exercise, Muscle, Gene Expression, Myokine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Dutch Diabetes Research Foundation
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Single legged exercise |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 40-60 years
- Male gender
- BMI < 30 kg/m2
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single legged exerciseA 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. | Other | Exercise |
Primary outcome
Gene expression changes in skeletal muscle from baseline to after exercise
Time frame: T = 0 and T =1
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
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)
3 secondary outcomes
PBMC gene expression changes before and after exercise
Time frame: T = 0, T = 1 and T =3
Routine plasma level changes before and after exercise
Time frame: T = 0, 1 and 3
Heart rate changes, baseline compared with exercise
Time frame: During the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single legged exercise in people with Exercise and Muscle, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression changes in skeletal muscle from baseline to after exercise (time frame: T = 0 and T =1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2011.