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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03189355
Acronym
Coc-SEPP1B
Enrollment
52
Registered
2017-06-16
Start date
2017-01-09
Completion date
2018-10-14
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Brief summary

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.

Interventions

PROCEDUREBlood sampling

* D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube * D4 zonulin

PROCEDUREMuscular echography

* D1 * D4

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PTP1B analysisDay 11 PAXgene tube (2,5 ml) will be used. RNA extraction will be done with a PAXgene Blood RNA System kit.
Muscular compositionDay 1Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T

Secondary

MeasureTime frameDescription
Intestinal permeabilityDay 11 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).
Body compositionDay 1Body composition will be measured by impedancemetry on D1 and D4

Countries

France

Contacts

PRINCIPAL_INVESTIGATORCaroline LEMAITRE

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026