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

Septic Shock Clinical Trial

— Coc-SEPP1B  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03189355
• Other study ID #: 2016/108/HP
• Status: Recruiting
• Phase: N/A
• First received: May 22, 2017
• Last updated: July 10, 2017
• Start date: January 9, 2017
• Est. completion date: February 9, 2019

Study information

• Verified date: July 2017
• Source: University Hospital, Rouen
• Contact: Caroline LEMAITRE, MD
• Phone: 232886697
• Email: Caroline.Lemaitre[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: February 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Procedure:
• Blood sampling
D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube D4 zonulin
• Bioelectrical impedance vector analysis
D1 D4
• Muscular echography
D1 D4

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTP1B analysis	1 PAXgene tube (2,5 ml) will be used. RNA extraction will be done with a PAXgene Blood RNA System kit.	Day 1
Primary	Muscular composition	Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T	Day 1
Primary	Muscular composition	Muscular composition will be measured by muscular echography with a 2B mode on D1 and D4 from the admission.T	Day 4
Secondary	Intestinal permeability	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).	Day 1
Secondary	Intestinal permeability	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).	Day 4
Secondary	Body composition	Body composition will be measured by impedancemetry on D1 and D4	Day 1
Secondary	Body composition	Body composition will be measured by impedancemetry on D1 and D4	Day 4