CClinicalTrials.gg
Status unknownNCT04209413COMMEFUpdated Jan 22, 2020

Control of the Opening of mPTP by Ex Vivo Measurements on Permeabilized Muscle Fibers (COMMEF)

An observational study in Anterior Cruciate Ligament Injuries, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-22.

Sponsored by University Hospital, Clermont-Ferrand · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study summary

mPTP (Mitochondrial Permeability Transition Pore) is a channel formed by a protein complex integrated into the inner membrane of mitochondria. Its opening is related to the elevation of the intra-mitochondrial calcium concentration and will result in: a mitochondrial decoupling, a rupture of the metabolic gradient and the release of pro-apoptotic factors.

The objective of this study is the development of a new ex vivo technique for characterizing mPTP by a dual measurement combining oxygraphy and fluorimetry on permeabilized skeletal muscle fibers.

Read the detailed description

The development of new expertise in the study of mPTP is part of an approach to optimize the processing of muscle samples. The aim of this work is to evaluate the feasibility and reproducibility of a method of analysis on muscle fibers only permeabilized, while coupling two complementary techniques, oxygraphy and fluorimetry. Its principle is based on the knowledge that the opening of the mPTP leads to an inhibition of respiration at the level of the complex I of the respiratory chain. This inhibition is the consequence of the escape from mitochondria of the reduced form of nicotinamide adenine dinucleotide (NADH, i.e. substrate of complex I) concomitant with the opening of mPTP. Thus, the oxygraphy must allow the observation of the inhibition of respiration synonymous with the non-availability of the substrate of the complex I and thus indirectly reflect the opening of the mPTP. For its part, the fluorimetry must allow, in the presence of a fluorescent calcium indicator (i.e. Calcium Green), the observation of the release of calcium synonymous with the opening of the mPTP.

Once validated, this technique should make it possible to evaluate in situ the sensitivity of mPTP to calcium. In a context of application within clinical protocols, the evaluation of the mPTP calcium sensitivity should contribute to a better understanding of the physiological and physio-pathological mechanisms of adaptation of muscle tissue.

02

Conditions studied

  • Anterior Cruciate Ligament Injuries

Keywords

  • Anterior Cruciate Ligament operation
  • Skeletal muscle
  • Mitochondria
  • Calcium
  • Mitochondrial permeability transition pore opening (mPTP opening)
03

In context

Anterior Cruciate Ligament Injuries

512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.

This study's planned enrollment of 40 is below the median of 92 across 127 observational studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients referred for a knee ligamentoplasty

Inclusion criteria

  • Patients aged over 18 ;
  • Patients referred for a knee ligamentoplasty (DIDT technique) ;
  • Patients who signed the non-opposition form after being informed ;
  • Patients benefiting from or affiliated to a social security.

Exclusion criteria

Exclusion Criteria:

  • Patients under guardianship, curatorship or deprived of liberty.
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Study design

Observational model
Other
Time perspective
Other
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • ProcedurePatients referred for a knee ligamentoplasty

    knee ligamentoplasty

06

What researchers measure

Primary outcomes

  1. Determination of the mPTP calcium sensitivity mPTP

    The goal is to study the feasibility of a new method for the analysis of the calcium sensitivity of mPTP on non-phantomized permeabilized muscle fibers by coupled use of oxygen and fluorimetry techniques. Calcium quantity and time required to open mPTPs in permeabilized muscle fibers will be measured, in the presence or absence of ciclosporin A, observable by total inhibition of mitochondrial respiration (synonymous with release of NADH).

    Time frame: day 0

Secondary outcomes

  1. Identification of mPTP opening discrimination factors

    Evaluate the possibility of population discrimination by this new method of analysis (i.e. variability by age and duration of functional impotence before intervention of the amount of calcium required to open the mPTP).

    Time frame: Day 0

07

Study locations

1 of 1 sites recruiting
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, 63000, France
    • Ruddy Richard · Contact · rrichard@chu-clermontferrand.fr
    • Ruddy Richard · Principal investigator
    • Stéphane Descamps · Sub investigator
    • Stéphane Boisgard · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04209413
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Centre de Recherche en Nutrition Humaine d'Auvergne
Responsible party
Sponsor
First posted
Dec 24, 2019
Start date
Jan 20, 2020
Primary completion
Nov 2020 (estimated)
Completion
Feb 2021 (estimated)
Last update
Jan 22, 2020

Study contacts

Lise LACLAUTRE
Contact
promo_interne_drci@chu-clermontferrand.fr
+334.73.754.963
Ruddy Richard
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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