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NCT Number: NCT03189355

Expression of Protein Tyrosine Phosphatase 1B (PTP1B) and Body Composition Modification in Patients With Septic Shock

With a prevalence of more than 15% in ICU, septic shock today represents a real public health problem and remains the leading cause of mortality in ICU. Undernutrition is characterized by an alteration of the body composition and in particular by a loss of muscle mass. In intensive care, there are indirect elements suggesting a link between loss of muscle mass and prognosis.

Muscle mass results from a balance between the pathway of proteolysis and that of protein synthesis, depending on many factors, not one of the most important are insulin. The protein PTP1B (Protein Tyrosine Phosphatase 1B), by the dephosphorylation of its numerous substrates, constitutes an endogenous regulator of numerous intracellular signaling pathways, including that of insulin. PTP1B could play a role in the protein synthesis abnormalities observed during sepsis leading clinically to impaired body composition including muscle body mass. Therefore, we propose to study the association between PTP1B and loss of muscle mass in patients in sepsis in resuscitation.

The intestinal barrier plays an essential role in protecting against microbial luminal flora and the phenomenon of bacterial translocation. Zonulin is one of the major regulators of tight junctions, important actors in the intestinal barrier function. The increase in plasma zonulin levels, greater than 0.6 ng / mg, is directly correlated with increased intestinal permeability (16). However, elevation of plasma zonulin has never been evaluated in septic resuscitation patients. This is why we propose the evaluation of the association between plasma zonulin and the loss of muscle mass in these resuscitation patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Septic shock or severe sepsis
  • Age > 18 years old
  • Affiliation to a social security system
  • Information and consent. If patient cannot give his consent, an emergency consent will be sign by trusted person
  • Contraception for woman, of childbearing age

Exclusion criteria

  • Pregnancy or breastfeeding
  • Prisoners
  • Patient with pacemaker or defibrillator
  • patient participating to a clinical trial with the same primary outcome

Treatment and study plan

blood sampling

Procedure
  • D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube
  • D4 zonulin

Bioelectrical impedance vector analysis

Procedure
  • D1
  • D4

Muscular echography

Procedure
  • D1
  • D4

Primary outcomes

  1. PTP1B analysis

    Time frame: Day 1

    1 PAXgene tube (2,5 ml) will be used. RNA extraction will be done with a PAXgene Blood RNA System kit.

  2. Muscular composition

    Time frame: Day 1

    Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T

  3. Muscular composition

    Time frame: Day 4

    Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T

Secondary outcomes

  1. Intestinal permeability

    Time frame: Day 1

    1 tube of 5 ml Aprotinin will be taken on D1 and D4 to determine the expression of plasma zonulin. The concentration will be assayed by ELISA using a commercial kit (MyBiosource, USA).

  2. Intestinal permeability

    Time frame: Day 4

    1 tube of 5 ml Aprotinin will be taken on D1 and D4 to determine the expression of plasma zonulin. The concentration will be assayed by ELISA using a commercial kit (MyBiosource, USA).

  3. Body composition

    Time frame: Day 1

    Body composition will be measured by impedancemetry on D1 and D4

  4. Body composition

    Time frame: Day 4

    Body composition will be measured by impedancemetry on D1 and D4

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: Coc-SEPP1B

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 16, 2017
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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