NCT04157556

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

November 11, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2020

Completed
Last Updated

April 30, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

November 5, 2019

Last Update Submit

April 28, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Level of MMP9 and TIMP1

    The effect of acute maximal exercise on serum MMP9 and TIMP1 levels in athletes and sedentary people.

    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.

    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

    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

    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)

Study Arms (2)

Group of athletes

EXPERIMENTAL

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

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.

Other: Yo-Yo Intermittent Recovery Test Level 1

Interventions

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.

Group of athletesGroup of sedentary people

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Sports Science

Izmir, Turkey (Türkiye)

Location

Study Officials

  • Faruk Turgay, associate professor

    Ege University, Faculty of Sports Science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 8, 2019

Study Start

November 11, 2019

Primary Completion

January 3, 2020

Study Completion

April 28, 2020

Last Updated

April 30, 2020

Record last verified: 2020-04

Locations