Genetic Determinants of Exercise-Induced Muscle Damage (POLYGENDOMUS) (POLYGENDOMUS)

December 13, 2024 updated by: Lille University

Genetic Determinants of Exercise-Induced Muscle Damage (POLYGENDOMUS) / Déterminants Génétiques Des Dommages Musculaires Induits Par L'exercice (POLYGENDOMUS)

The objective of this study is to evaluate the association between the evolution of plasma CPK levels and genetic polymorphisms, both before the muscle-damaging exercise and at three post-exercise time points. The investigators aim to include 300 participants in this research.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Elite-level sports expose athletes to training loads designed to induce muscle damage, aiming to achieve optimal physiological adaptations. However, the repetitive nature of such damage increases the risk of injury. The ability to assess an athlete's susceptibility to fragility is therefore crucial for optimizing their training and performance. Genetic factors appear to play a significant role in the occurrence of these injuries, particularly through subtle variations in DNA sequences. Depending on the location of these variations within a gene, they may or may not alter the expression or function of the associated protein. The investigators aimed to investigate the relationship between genetic polymorphisms and biological parameters in the context of exercise-induced muscle damage.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or female
  • Aged between 18 and 35
  • Weighing more than 50 kg
  • Member of a sports club affiliated to an Olympic federation
  • Socially insured
  • Willing to comply with all study procedures and duration of the study

Exclusion Criteria:

  • Medical history contraindicating sporting activities
  • Current medical treatment
  • Not a member of a sports club affiliated to an Olympic federation
  • Administrative reasons: impossibility of receiving informed information, impossibility of participating in the entire study, absence of social security coverage, refusal to sign consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
exercise group
Other: Exercise
Muscle induced-damage eccentric exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The association between single nucleotide polymorphisms and exercise induced blood creatine kinase variation
Time Frame: Evolution of kinetics from Day 0 to Day 3 post experiment

Association between blood creatine kinase level variations and single nucleotide polymorphisms.

The Outcome Measure in this study is focused on the variation in plasma CPK levels following an exercise inducing muscle damage. The result is expressed as a change in plasma CPK concentration, measured in units per liter (U/L). This single measurement is used to investigate its association with genetic polymorphisms. Therefore a regression analysis will be performed to identify the association. This study is exploratory and the genetic polymorphisms are not pre-identified but will be investigated through a comprehensive analysis.
Evolution of kinetics from Day 0 to Day 3 post experiment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Actual)

June 28, 2024

Study Completion (Estimated)

December 19, 2025

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2022-007
  • 2022-A01308-35 (Other Identifier: Agence nationale de sécurité du médicament et des produits de santé)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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