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The Effect of Maximal Exercise on MMP9 and TIMP1 and The Role of MMP9 -1562 C/T and TIMP1 372 T/C Polymorphisms

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ClinicalTrials.gov Identifier: NCT04157556
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : January 6, 2020
Sponsor:
Collaborator:
Ege University
Information provided by (Responsible Party):
Merve Koca Kosova, Dokuz Eylul University

Brief 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. 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:

  1. Levels of basal serum MMP9 and TIMP1 are different between athletes (volleyball, basketball, handball) and sedentary people.
  2. Levels of serum MMP9 and TIMP1 response to maximal exercise are different between athletes (volleyball, basketball, handball) and sedentary people .
  3. Relationship between levels of serum MMP9 and TIMP1 response to maximal exercise are different between athletes (volleyball, basketball, handball) and sedentary people.
  4. Levels of basal serum MMP9 and TIMP1 are related to MMP9 -1562 C/T and TIMP1 372 T/C polymorphisms.
  5. 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.

Condition or disease Intervention/treatment Phase
MMP9 TIMP1 MMP9 -1562 C/T TIMP1 372 T/C Other: Yo-Yo Intermittent Recovery Test Level 1 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 11, 2019
Actual Primary Completion Date : January 3, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group of athletes
Age: 18-35 Gender: Male Basketball, volleyball, handball players who have been training regularly for at least last 3 months.
Other: Yo-Yo Intermittent Recovery Test Level 1

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.


Experimental: Group of sedentary people
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.
Other: Yo-Yo Intermittent Recovery Test Level 1

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.





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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) ]

    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), Thiobarbituric Acid Reactive Species (TBARS), total antioxidant status (TAS), total oxidant status (TOS), nitric oxide (NO)


  2. 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) ]
    The relationship between primary outcome measures and blood lipids and lipoproteins, glucose, urea, creatinine and hemogram



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria(For two groups):

  • Smoking regularly
  • Drinking alcohol regularly
  • Using drug and antioxidant substance
  • Being obese,
  • Being sick or having disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157556


Contacts
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Contact: Faruk Turgay, associate professor +902323425714 fturgay@yahoo.com

Locations
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Turkey
Ege University Faculty of Sports Science Recruiting
İzmir, Turkey
Contact: Faruk Turgay    +902323425714    sporbilimleri@mail.ege.edu.tr   
Sponsors and Collaborators
Dokuz Eylul University
Ege University
Investigators
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Study Chair: Faruk Turgay, associate professor Ege University, Faculty of Sports Science

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Responsible Party: Merve Koca Kosova, research assistant, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT04157556    
Other Study ID Numbers: 18-7.1/49
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tissue Inhibitor of Metalloproteinase-1
Matrix Metalloproteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action