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DrepanocytoseNCT02874170

Study of the Function and Muscle Metabolism in Drepanocytose Affected Patient During a Moderate Intensity Exercise

A study testing Spectroscopy magnetic resonance of phosphorus 31 in people with Drepanocytose, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Drepanocytose disease is the first genetic disease in the world. It results in the synthesis of an abnormal hemoglobin (HbS), which in its deoxygenated form, polymerizes and leads to structural changes of red blood cells (RBC) which then take the shape of a sickle, become more fragile, more rigid and less deformable. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Drepanocytose
What is being tested?
Spectroscopy magnetic resonance of phosphorus 31
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteFrance
Study dates
Jul 2015to Jul 2019
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient affected by sickel cells and healthy volonteers presenting no contre indication to spectrometry exam.

Who cannot join

  • Patient affected by hemoglobinopathies other than drepanocytose

Trial locations and contacts

1 site in 1 country.

Jean-Pierre MATTEI, MD contact

jean-pierre.mattei@ap-hm.fr

david BENDAHAN, PhD contact

david.bendahan@univ-amu.fr

France1 site, 1 recruiting
  • Assistance Publique Hôpitaux de Marseille

    Marseille, 13354

    David BENDAHAN, PhD, davide.bendahan@univ-amu.fr

    Recruiting

Other trials in France

About this study

Drepanocytose disease is the first genetic disease in the world. It results in the synthesis of an abnormal hemoglobin (HbS), which in its deoxygenated form, polymerizes and leads to structural changes of red blood cells (RBC) which then take the shape of a sickle, become more fragile, more rigid and less deformable. The fragility of GR sickle causes their mass destruction, leading to chronic anemia (i.e. low levels of GR in the blood) associated with low tissue oxygenation. More rigid and less deformable, sickle GR tend to hang in the microvessels, leading to vaso-occlusive crises (CVO) particularly painful, can cause the failure of certain organs (spleen, kidneys, brain, lung, heart, liver , bone ...) and to life-threatening patients. Preliminary studies conducted on patients with drepanocytose disease (HbSS) have demonstrated changes of muscle tissue indicating a possible failure in the supply and use of oxygen. To date, the translation of this metabolic remodeling in the muscle work is not known.

This project's main objective is to evaluate muscle function in drepanocytose attempted patients. We hypothesized that muscle remodeling associated with sickle cell disease have a functional impact on strength and muscle metabolism. The main objective is to characterize the maximal voluntary plantar flexor muscles. The criteria for these targets will be based on the comparison between healthy subjects, carriers of the sickle cell trait (HbAS) and sickle cell patients (HbSS) oxygen saturation.

The strictly non-invasive approach proposed in this project will study the functional parameters of the muscle of sickle cell disease and the possible link with the clinical manifestations of the disease, including vaso-occlusive crisis, in which tissue oxygenation and pH plays a major role.

Conditions
Drepanocytose
Being tested
Spectroscopy magnetic resonance of phosphorus 31

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spectroscopy magnetic resonance of phosphorus 31Other

Study groups in NCT02874170
Study groupRoleWhat they receive
drepanocytose affected patientExperimentalNot described
Receives: Other: Spectroscopy magnetic resonance of phosphorus 31
Healthy volunteersOtherNot described
Receives: Other: Spectroscopy magnetic resonance of phosphorus 31

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of phosphorus 31released during muscle exercise assesses by magnetic resonance spectroscopy

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

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
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02874170
Sponsor's protocol ID
2014-39
Other IDs
2014-A01486-41
Status last verified
Aug 2016
First submitted
17 Aug 2016
Last updated
22 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Spectroscopy magnetic resonance of phosphorus 31 in people with Drepanocytose, run by Assistance Publique Hopitaux De Marseille at 1 site in France.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Aug 2016. 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 France. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jean-Pierre MATTEI, MD (jean-pierre.mattei@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of phosphorus 31released during muscle exercise assesses by magnetic resonance spectroscopy (time frame: 2 hours). 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 22 Aug 2016.

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