MMP9NCT04157556
The Effect of Maximal Exercise on MMP9 and TIMP1 and The Role of MMP9 -1562 C/T and TIMP1 372 T/C Polymorphisms
A study testing Yo-Yo Intermittent Recovery Test Level 1 in people with MMP9 and TIMP1, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Matrix metalloproteinases (MMPs) play a critical role in the remodeling and regeneration of skeletal muscle. Studies which investigate exercise and effects of MMPs and tissue inhibitors of matrix metalloproteinases (TIMPs) are contradictory. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- MMP9, TIMP1, MMP9 -1562 C/T
- What is being tested?
- Yo-Yo Intermittent Recovery Test Level 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2019to 28 Apr 2020
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Group of athletes:
- Male basketball players who have been training regularly for at least last 3 months.
- Male volleyball players who have been training regularly for at least last 3 months.
- Male handball players who have been training regularly for at least last 3 months.
- Group of sedentary people:
- Male individuals with similar physical characteristics to the group of athletes
- Male individuals who have not exercise regularly for at least last 3 months.
Who cannot join
- Smoking regularly
- Drinking alcohol regularly
- Using drug and antioxidant substance
- Being obese,
- Being sick or having disability
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Sports Science
Izmir
About this study
Official title: The Effect of Maximal Exercise on Matrix Metalloproteinase Enzyme and Its Inhibitor (MMP9 and TIMP1) and The Role of MMP9 -1562 C/T and TIMP1 372 T/C Polymorphisms
Matrix metalloproteinases (MMPs) play a critical role in the remodeling and regeneration of skeletal muscle. Studies which investigate exercise and effects of MMPs and tissue inhibitors of matrix metalloproteinases (TIMPs) are contradictory. Also the role of MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms on exercise are unclear. In accordance with this conditions the hypothesis of the study are as follows:
- Levels of basal serum MMP9 and TIMP1 are different between athletes (volleyball, basketball, handball) and sedentary people.
- Levels of serum MMP9 and TIMP1 response to maximal exercise are different between athletes (volleyball, basketball, handball) and sedentary people .
- Relationship between levels of serum MMP9 and TIMP1 response to maximal exercise are different between athletes (volleyball, basketball, handball) and sedentary people.
- Levels of basal serum MMP9 and TIMP1 are related to MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms.
- Relationship between levels of serum MMP9 and TIMP1 response to maximal exercise and MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms are different between athletes (volleyball, basketball, handball) and sedentary people.
- Conditions
- MMP9, TIMP1, MMP9 -1562 C/T, TIMP1 372 T/C
- Being tested
- Yo-Yo Intermittent Recovery Test Level 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yo-Yo Intermittent Recovery Test Level 1Other
The test is a standard test battery with progressively increasing speeds. After every 40-m run (2x20 m), active rest is performed by walking or jogging at a distance of 10 m (2x5 m). for 10 seconds. Participants are trying to adjust their speed according to incoming audio signals.The test is terminated when the participants can not reach the signal twice. The test ends in 10-20 minutes depending on the level of participants.
Reference Bangsbo, J., Iaia, F. M., \& Krustrup, P. (2008). The Yo-Yo intermittent recovery test. Sports medicine, 38(1), 37-51.
Krustrup, P., Mohr, M., Amstrup, T., Rysgaard, T., Johansen, J., Steensberg, A., ... \& Bangsbo, J. (2003). The yo-yo intermittent recovery test: physiological response, reliability, and validity. Medicine \& Science in Sports \& Exercise, 35(4), 697-705.
| Study group | Role | What they receive |
|---|---|---|
| Group of athletes | Experimental | Age: 18-35 Gender: Male Basketball, volleyball, handball players who have been training regularly for at least last 3 months. Receives: Other: Yo-Yo Intermittent Recovery Test Level 1 |
| Group of sedentary people | Experimental | Age: 18-35 Gender: Male Individuals with similar physical characteristics to the group of athletes and who have not exercise regularly for at least last 3 months. Receives: Other: Yo-Yo Intermittent Recovery Test Level 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of MMP9 and TIMP1
The effect of acute maximal exercise on serum MMP9 and TIMP1 levels in athletes and sedentary people.
Measured: Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)
MMP9 -1562 C/T, TIMP1 372 T/C polymorphisms
The role of MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms on the effect of acute maximal exercise on serum MMP9 and TIMP1 in athletes and sedentary people.
Measured: Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)
Secondary outcomes (2)
Level of indicators of muscle damage and inflammation and oxidative stress
The relationship between primary outcome measures and indicators of muscle damage, inflammation and oxidative stress.
Indicators to be determined: creatine kinase (CK), aspartate aminotransferase (AST), alanine aminotransferase (ALT), Interleukin-6 (IL-6), C- reactive protein (CRP), total antioxidant status (TAS), total oxidant status (TOS), nitric oxide (NO)
Measured: Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)
Level of blood lipids and lipoproteins, glucose, urea, creatinine, hemogram
The relationship between primary outcome measures and blood lipids and lipoproteins, glucose, urea, creatinine and hemogram
Measured: Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start11 Nov 2019
- Primary completion3 Jan 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MMP9Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups in the study: Athletes and sedentary people.They will apply the same acute exercise protocol (The Yo-Yo Intermittent Recovery Test Level 1). A blood test will conduct before and after the acute exercise protocol.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, Merve Koca Kosova, Dokuz Eylul University
- Investigators
- Faruk Turgay, associate professor, Study chair, Ege University, Faculty of Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157556
- Sponsor's protocol ID
- 18-7.1/49
- Status last verified
- Apr 2020
- First submitted
- 5 Nov 2019
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Maximal Exercise on Matrix Metalloproteinase Enzyme and Its Inhibitor (MMP9 and TIMP1) and The Role of MMP9 -1562 C/T and TIMP1 372 T/C Polymorphisms
- ClinicalTrials.gov ID
- NCT04157556
- Acronym / sponsor ID
- 18-7.1/49
- Conditions
- MMP9, TIMP1, MMP9 -1562 C/T, TIMP1 372 T/C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 8 Nov 2019 (actual)
- 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.
Matrix metalloproteinases (MMPs) play a critical role in the remodeling and regeneration of skeletal muscle. Studies which investigate exercise and effects of MMPs and tissue inhibitors of matrix metalloproteinases (TIMPs) are contradictory. Also the role of MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms on exercise are unclear. In accordance with this conditions the hypothesis of the study are as follows:
- Levels of basal serum MMP9 and TIMP1 are different between athletes (volleyball, basketball, handball) and sedentary people.
- Levels of serum MMP9 and TIMP1 response to maximal exercise are different between athletes (volleyball, basketball, handball) and sedentary people .
- Relationship between levels of serum MMP9 and TIMP1 response to maximal exercise are different between athletes (volleyball, basketball, handball) and sedentary people.
- Levels of basal serum MMP9 and TIMP1 are related to MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms.
- Relationship between levels of serum MMP9 and TIMP1 response to maximal exercise and MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms are different between athletes (volleyball, basketball, handball) and sedentary people.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are 2 groups in the study: Athletes and sedentary people.They will apply the same acute exercise protocol (The Yo-Yo Intermittent Recovery Test Level 1). A blood test will conduct before and after the acute exercise protocol.
| Arm | Type | Receives |
|---|---|---|
| Group of athletes | Experimental | Other: Yo-Yo Intermittent Recovery Test Level 1Age: 18-35 Gender: Male Basketball, volleyball, handball players who have been training regularly for at least last 3 months. |
| Group of sedentary people | Experimental | Other: Yo-Yo Intermittent Recovery Test Level 1Age: 18-35 Gender: Male Individuals with similar physical characteristics to the group of athletes and who have not exercise regularly for at least last 3 months. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male basketball players who have been training regularly for at least last 3 months.
- Male volleyball players who have been training regularly for at least last 3 months.
- Male handball players who have been training regularly for at least last 3 months.
- Male individuals with similar physical characteristics to the group of athletes
- Male individuals who have not exercise regularly for at least last 3 months.
Key exclusion criteria (5 listed)
- Smoking regularly
- Drinking alcohol regularly
- Using drug and antioxidant substance
- Being obese,
- Being sick or having disability
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 |
|---|---|---|
| Yo-Yo Intermittent Recovery Test Level 1The test is a standard test battery with progressively increasing speeds. After every 40-m run (2x20 m), active rest is performed by walking or jogging at a distance of 10 m (2x5 m). for 10 seconds. Participants are trying to adjust their speed according to incoming audio signals.The test is terminated when the participants can not reach the signal twice. The test ends in 10-20 minutes depending on the level of participants. Reference Bangsbo, J., Iaia, F. M., \& Krustrup, P. (2008). The Yo-Yo intermittent recovery test. Sports medicine, 38(1), 37-51. Krustrup, P., Mohr, M., Amstrup, T., Rysgaard, T., Johansen, J., Steensberg, A., ... \& Bangsbo, J. (2003). The yo-yo intermittent recovery test: physiological response, reliability, and validity. Medicine \& Science in Sports \& Exercise, 35(4), 697-705. | Other | Group of athletes, Group of sedentary people |
Primary outcome
Level of MMP9 and TIMP1
Time frame: Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)
The effect of acute maximal exercise on serum MMP9 and TIMP1 levels in athletes and sedentary people.
MMP9 -1562 C/T, TIMP1 372 T/C polymorphisms
Time frame: Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)
The role of MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms on the effect of acute maximal exercise on serum MMP9 and TIMP1 in athletes and sedentary people.
2 secondary outcomes
Level of indicators of muscle damage and inflammation and oxidative stress
Time frame: Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)
Level of blood lipids and lipoproteins, glucose, urea, creatinine, hemogram
Time frame: Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)
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 30 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Faruk Turgay, associate professor study chair
Ege University, Faculty of Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yo-Yo Intermittent Recovery Test Level 1 in people with MMP9 and TIMP1, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 7 inclusion and 5 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 30 Apr 2020. 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 Turkey (Türkiye). 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?
Level of MMP9 and TIMP1 (time frame: Yo-Yo Intermittent Recovery Test level 1 (the test performed until the subject is exhausted, the test lasts 10-20 minutes according to endurance capacity of the participants)). 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 30 Apr 2020.