<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04432337</url>
  </required_header>
  <id_info>
    <org_study_id>19_RIPH2-15</org_study_id>
    <nct_id>NCT04432337</nct_id>
  </id_info>
  <brief_title>Role of Type 2 Diabetes in Potentiating the Inflammatory Response Post Extracorporeal Circulation After Cardiac Surgery</brief_title>
  <acronym>DT2CEC</acronym>
  <official_title>Role of Type 2 Diabetes in Potentiating the Inflammatory Response Post Extracorporeal Circulation, Mediated by the NLRP3 Inflammasome, in Patients After Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Center of Martinique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Center of Martinique</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adult cardiac surgery ensures the surgical treatment of valvular and coronary pathologies and&#xD;
      of heart failure with the placement of ventricular assistance. Extracorporeal circulation&#xD;
      (ECC) is one of the major technical advances associated with cardiac surgery to replace&#xD;
      cardiac and pulmonary functions during surgery. ECC can nevertheless lead to postoperative&#xD;
      complications, the origin of which is linked to the patient's initial contact with the&#xD;
      circuit and membranes of the ECC. This contact triggers a series of humoral and cellular&#xD;
      reactions that occur in the first few hours after the ECC and the inflammatory syndrome post&#xD;
      ECC fades on its own and usually disappears between the 4th and 6th postoperative day. If the&#xD;
      inflammatory response post ECC is most often transient, certain conditions will maintain and&#xD;
      intensify this response at the origin of postoperative complications, possibly leading to the&#xD;
      patient's death. Among these situations, the investigators find the notion of emergency&#xD;
      cardiac surgery, a patient's age over 75 years and a preoperative history of decompensated&#xD;
      heart failure, renal failure or type 2 diabetes (T2D).&#xD;
&#xD;
      The inflammasome family of receptors of the nucleotide oligomerization domain (NOD) type,&#xD;
      pyrin domain containing 3, NLRP3, is a multi-protein platform of recent discovery which plays&#xD;
      a major role in the signaling pathways of the innate inflammatory response.&#xD;
&#xD;
      The role of the activation of the NLRP3 inflammasome in cardiovascular pathologies is now&#xD;
      well established and its metabolic priming by hyperglycemia could explain the greater&#xD;
      seriousness of these pathologies in T2D patients due to an exacerbated inflammatory response.&#xD;
&#xD;
      What is the effect of T2D status on the inflammatory response post ECC, mediated by the NLRP3&#xD;
      inflammasome, in patients after cardiac surgery?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult cardiac surgery provides surgical treatment of valvular, coronary, and heart failure&#xD;
      pathologies with the installation of ventricular assistance. Extracorporeal circulation (ECC)&#xD;
      is one of the major technical advances associated with cardiac surgery to replace cardiac and&#xD;
      pulmonary functions during surgery. However, ECC can lead to postoperative complications, the&#xD;
      origin of which is linked to the patient's initial contact with the circuit and membranes of&#xD;
      the ECC. This contact triggers a series of humoral and cellular reactions such as activation&#xD;
      of the plasma contact system and complement, coagulation and fibrinolysis, activation of&#xD;
      endothelial cells and leukocytes, as well as the release into the circulating blood of many&#xD;
      mediators of inflammation such as cytokines TNF-α, interleukin IL -1β, interleukin IL6 and&#xD;
      interleukin IL8. These reactions occur in the first hours after the ECC and the inflammatory&#xD;
      syndrome post ECC fades by itself and usually disappears between the 4th and 6th&#xD;
      postoperative day. Different technical and pharmacological modalities (biocompatibility of&#xD;
      circuits, hemofiltration, leukocyte filter, antioxidants, anti-inflammatories, corticoids)&#xD;
      have helped reduce the inflammatory syndrome post ECC, but their partial effectiveness&#xD;
      highlights the need to better understand the molecular mechanisms of inflammation. post ECC&#xD;
      in order to improve its prevention.&#xD;
&#xD;
      If the inflammatory response post ECC is most often transient, certain conditions will&#xD;
      maintain and intensify this response at the origin of postoperative complications, possibly&#xD;
      leading to the patient's death. Among these situations, The investigators find the notion of&#xD;
      emergency cardiac surgery, a patient's age&gt; 75 years and a preoperative history of&#xD;
      decompensated heart failure, renal failure or type 2 diabetes (T2D).&#xD;
&#xD;
      Defined according to the criteria proposed by the World Health Organization (WHO) and the&#xD;
      American Diabetes Association (ADA), DT2 is a major independent risk factor for morbidity and&#xD;
      mortality from general surgery, and from surgery especially the heart. The risk of&#xD;
      cardiovascular and infectious complications after cardiac surgery in T2D patients increases&#xD;
      by 17% for each unit of glycemia above 6 mmol / L. Strict control of blood sugar during the&#xD;
      perioperative phase, however, significantly reduces the risk of complications in T2D&#xD;
      patients. Physiopathologically, the higher incidence of postoperative complications in T2D&#xD;
      patients is attributed to the exacerbation of the postoperative inflammatory response and its&#xD;
      deleterious effects on vascular function. A recent study confirms that the expression of&#xD;
      messenger RNAs coding for the inflammation genes (IL-1β, IL8) and the transitional activation&#xD;
      factors (MYC / JUN) is increased in T2D patients and that this chronic state of low grade&#xD;
      preoperative would promote deregulation of the inflammatory response after cardiac surgery,&#xD;
      and the occurrence of cardiovascular complications. The level of inflammation in T2D patients&#xD;
      is also usually reflected by an increase in plasma levels of proteins in the acute phase of&#xD;
      inflammation (C-reactive protein CRP, in particular) and other pro-inflammatory cytokines&#xD;
      (TNF-α IL6). These different results suggest that the activation of the NOD-like receptor&#xD;
      family pyrin domain containing 3, (NLRP3) inflammasome may play a central role in low-level&#xD;
      chronic inflammatory status in T2D patients.&#xD;
&#xD;
      The inflammasome NOD-like receptor family pyrin domain containing 3, NLRP3, is a&#xD;
      multi-protein platform whose activation is involved in the signaling pathways of the innate&#xD;
      inflammatory response in many inflammatory and infectious diseases, as well as metabolic&#xD;
      pathologies like gout and type 2 diabetes. The assembly of the NLRP3 inflammasome results in&#xD;
      the activation of inflammatory caspases allowing the cleavage of the pro-cytokines IL-1β and&#xD;
      IL-18 into mature and active cytokines. Several studies show that T2D hyperglycemia is a&#xD;
      pre-activation or priming factor for NLRP3 which potentiates the secondary activation of&#xD;
      NLRP3 and the synthesis of the interleukins of IL-1β and IL18. During T2D, other metabolic&#xD;
      signals such as the accumulation of free fatty acids, the release of cellular debris&#xD;
      (damage-associated molecular patterns, DAMPs), and reactive oxygen species (ROS) are also&#xD;
      responsible for the priming of NLRP3. Among the molecular motifs DAMPs, mitochondrial DNA&#xD;
      (mtDNA) is a powerful activator of the NLRP3 inflammasome due to the ancestral bacterial&#xD;
      origin of mitochondria.&#xD;
&#xD;
      The role of the activation of the NLRP3 inflammasome in cardiovascular pathologies is now&#xD;
      well established and its metabolic priming by hyperglycemia could explain the greater&#xD;
      seriousness of these pathologies in T2D patients due to an exacerbated inflammatory response.&#xD;
      Currently, there is no human data on the role of NLRP3 inflammasome activation in post-ECC&#xD;
      inflammatory syndrome. The investigators envision that the extracorporeal circulation (ECC),&#xD;
      responsible for cellular damage, is accompanied by a release of molecular patterns of DAMPs&#xD;
      type at the origin of the activation of the NLRP3 inflammasome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Departure of the principal investigator&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Type 2 diabetics patients</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Variation in the plasma concentration of cytokines IL-1β and IL18</measure>
    <time_frame>48 hours</time_frame>
    <description>The variation in the plasma concentration of the two pro-inflammatory cytokines IL-1β and IL18, between a baseline level measured the day before the operating room (D-1) and 24 hours (D1) after cardiac surgery with ECC. The variation in their concentrations is measured between D-1 and D1 in order to assess the inflammatory response occurring in the first hours post ECC, and mediated by the NLRP3 inflammasome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare the plasma levels of IL-1β and IL18</measure>
    <time_frame>Compare between Day-1 and Day 7</time_frame>
    <description>The plasma levels of IL-1β and IL18 will be determined using commercial assay kits (ELISA technique and expressed in pg / mL).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Compare the plasma concentration of mitochondrial (damage-associated molecular patterns) DAMPS</measure>
    <time_frame>Compare between Day-1 and Day 7</time_frame>
    <description>Plasma mitochondrial DNA plasma concentration will be achieved by the real-time polymerase chain reaction (PCR). The results will be expressed in number of copies of DNA per microliter.</description>
  </other_outcome>
  <other_outcome>
    <measure>Compare the level of activation of the NLRP3 inflammasome in circulating blood monocytes</measure>
    <time_frame>Compare between Day-1 and Day 7</time_frame>
    <description>The level of activation of the NLRP3 inflammasome in circulating blood monocytes, expressed by the number of copies of NLRP3 mRNA measured in quantitative RT-PCR (RT-qPCR) in monocytes isolated from circulating blood.</description>
  </other_outcome>
  <other_outcome>
    <measure>Compare the plasma concentration of reactive protein C (CRP) the level of activation of the NLRP3 inflammasome in circulating blood monocytes.</measure>
    <time_frame>Compare between Day-1 and Day 7</time_frame>
    <description>CRP is a protein synthesized by the liver whose expression increases during the acute phase of inflammation</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Inflammatory Response</condition>
  <condition>Extracorporeal Circulation; Complications</condition>
  <condition>Cardiac Surgery</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Type 2 diabetes patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The variation in the plasma concentration of the two pro-inflammatory cytokines IL-1β and IL18, between a baseline level measured the day before the operating room (D-1) and 24 hours (D1) for TD2 patients after cardiac surgery with extracorporeal circulation .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-diabetic type 2 patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The variation in the plasma concentration of the two pro-inflammatory cytokines IL-1β and IL18, between a baseline level measured the day before the operating room (D-1) and 24 hours (D1) for non-diabetic type 2 patients after cardiac surgery with extracorporeal circulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The role of the activation of the NLRP3 inflammasome after cardiac surgery</intervention_name>
    <description>Determine the effect on the inflammatory response post extracorporeal circulation mediated by the NLRP3 inflammasome, in patients after cardiac surgery</description>
    <arm_group_label>Non-diabetic type 2 patients</arm_group_label>
    <arm_group_label>Type 2 diabetes patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 18 and 75 years old&#xD;
&#xD;
          -  Type 2 diabetic patients (WHO definition and American Diabetes Association) according&#xD;
             to the following criteria: fasting blood glucose ≥ 7.0 mmol / L (fasting = no caloric&#xD;
             proportion for at least 8 h) or glycosylated hemoglobin level HbA1c ≥ 6, 5% (in&#xD;
             adults), or blood sugar 2 hours after ingestion of 75 g of glucose ≥ 11.1 mmol / L, or&#xD;
             random blood sugar ≥ 11.1 mmol / L, either at any time of the day, without seeing at&#xD;
             the time of the last meal.&#xD;
&#xD;
          -  Patients undergoing aortocoronary bypass surgery or valve replacement with&#xD;
             extracorporeal circulation at the university hospital of Martinique&#xD;
&#xD;
          -  Patients able to receive and understand information related to research and blood&#xD;
             samples taken during treatment&#xD;
&#xD;
          -  Patients able to freely express informed and written consent&#xD;
&#xD;
          -  Patients supported by french social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerable people: people deprived of their liberty by a judicial or administrative&#xD;
             decision, subjects admitted to a health or social protection establishment, major&#xD;
             subjects under legal protection (guardianship or curatorship) or under the protection&#xD;
             of justice, patients in situation emergency. Pregnant or lactating women, or women of&#xD;
             childbearing potential without effective contraception. People with a state of health&#xD;
             incompatible with the follow-up of the protocol (psychiatric disorders, uncontrolled&#xD;
             disease), having cognitive disorders which do not allow the understanding of the&#xD;
             study.&#xD;
&#xD;
          -  Type 1 diabetic patient&#xD;
&#xD;
          -  Patient who has a systemic inflammatory disease&#xD;
&#xD;
          -  Patient who has an autoimmune disease&#xD;
&#xD;
          -  Patient who has a cancer pathology&#xD;
&#xD;
          -  Patient who has contraindications related to surgical operations in general such as&#xD;
             general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Martinique</name>
      <address>
        <city>Fort-de-France</city>
        <zip>97261</zip>
        <country>Martinique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Martinique</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04432337
org study id: 19_RIPH2-15
nct id: NCT04432337
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Adult cardiac surgery ensures the surgical treatment of valvular and coronary pathologies and
      of heart failure with the placement of ventricular assistance. Extracorporeal circulation
      (ECC) is one of the major technical advances associated with cardiac surgery to replace
      cardiac and pulmonary functions during surgery. ECC can nevertheless lead to postoperative
      complications, the origin of which is linked to the patient's initial contact with the
      circuit and membranes of the ECC. This contact triggers a series of humoral and cellular
      reactions that occur in the first few hours after the ECC and the inflammatory syndrome post
      ECC fades on its own and usually disappears between the 4th and 6th postoperative day. If the
      inflammatory response post ECC is most often transient, certain conditions will maintain and
      intensify this response at the origin of postoperative complications, possibly leading to the
      patient's death. Among these situations, the investigators find the notion of emergency
      cardiac surgery, a patient's age over 75 years and a preoperative history of decompensated
      heart failure, renal failure or type 2 diabetes (T2D).

      The inflammasome family of receptors of the nucleotide oligomerization domain (NOD) type,
      pyrin domain containing 3, NLRP3, is a multi-protein platform of recent discovery which plays
      a major role in the signaling pathways of the innate inflammatory response.

      The role of the activation of the NLRP3 inflammasome in cardiovascular pathologies is now
      well established and its metabolic priming by hyperglycemia could explain the greater
      seriousness of these pathologies in T2D patients due to an exacerbated inflammatory response.

      What is the effect of T2D status on the inflammatory response post ECC, mediated by the NLRP3
      inflammasome, in patients after cardiac surgery?
Adult cardiac surgery provides surgical treatment of valvular, coronary, and heart failure
      pathologies with the installation of ventricular assistance. Extracorporeal circulation (ECC)
      is one of the major technical advances associated with cardiac surgery to replace cardiac and
      pulmonary functions during surgery. However, ECC can lead to postoperative complications, the
      origin of which is linked to the patient's initial contact with the circuit and membranes of
      the ECC. This contact triggers a series of humoral and cellular reactions such as activation
      of the plasma contact system and complement, coagulation and fibrinolysis, activation of
      endothelial cells and leukocytes, as well as the release into the circulating blood of many
      mediators of inflammation such as cytokines TNF-α, interleukin IL -1β, interleukin IL6 and
      interleukin IL8. These reactions occur in the first hours after the ECC and the inflammatory
      syndrome post ECC fades by itself and usually disappears between the 4th and 6th
      postoperative day. Different technical and pharmacological modalities (biocompatibility of
      circuits, hemofiltration, leukocyte filter, antioxidants, anti-inflammatories, corticoids)
      have helped reduce the inflammatory syndrome post ECC, but their partial effectiveness
      highlights the need to better understand the molecular mechanisms of inflammation. post ECC
      in order to improve its prevention.

      If the inflammatory response post ECC is most often transient, certain conditions will
      maintain and intensify this response at the origin of postoperative complications, possibly
      leading to the patient's death. Among these situations, The investigators find the notion of
      emergency cardiac surgery, a patient's age> 75 years and a preoperative history of
      decompensated heart failure, renal failure or type 2 diabetes (T2D).

      Defined according to the criteria proposed by the World Health Organization (WHO) and the
      American Diabetes Association (ADA), DT2 is a major independent risk factor for morbidity and
      mortality from general surgery, and from surgery especially the heart. The risk of
      cardiovascular and infectious complications after cardiac surgery in T2D patients increases
      by 17% for each unit of glycemia above 6 mmol / L. Strict control of blood sugar during the
      perioperative phase, however, significantly reduces the risk of complications in T2D
      patients. Physiopathologically, the higher incidence of postoperative complications in T2D
      patients is attributed to the exacerbation of the postoperative inflammatory response and its
      deleterious effects on vascular function. A recent study confirms that the expression of
      messenger RNAs coding for the inflammation genes (IL-1β, IL8) and the transitional activation
      factors (MYC / JUN) is increased in T2D patients and that this chronic state of low grade
      preoperative would promote deregulation of the inflammatory response after cardiac surgery,
      and the occurrence of cardiovascular complications. The level of inflammation in T2D patients
      is also usually reflected by an increase in plasma levels of proteins in the acute phase of
      inflammation (C-reactive protein CRP, in particular) and other pro-inflammatory cytokines
      (TNF-α IL6). These different results suggest that the activation of the NOD-like receptor
      family pyrin domain containing 3, (NLRP3) inflammasome may play a central role in low-level
      chronic inflammatory status in T2D patients.

      The inflammasome NOD-like receptor family pyrin domain containing 3, NLRP3, is a
      multi-protein platform whose activation is involved in the signaling pathways of the innate
      inflammatory response in many inflammatory and infectious diseases, as well as metabolic
      pathologies like gout and type 2 diabetes. The assembly of the NLRP3 inflammasome results in
      the activation of inflammatory caspases allowing the cleavage of the pro-cytokines IL-1β and
      IL-18 into mature and active cytokines. Several studies show that T2D hyperglycemia is a
      pre-activation or priming factor for NLRP3 which potentiates the secondary activation of
      NLRP3 and the synthesis of the interleukins of IL-1β and IL18. During T2D, other metabolic
      signals such as the accumulation of free fatty acids, the release of cellular debris
      (damage-associated molecular patterns, DAMPs), and reactive oxygen species (ROS) are also
      responsible for the priming of NLRP3. Among the molecular motifs DAMPs, mitochondrial DNA
      (mtDNA) is a powerful activator of the NLRP3 inflammasome due to the ancestral bacterial
      origin of mitochondria.

      The role of the activation of the NLRP3 inflammasome in cardiovascular pathologies is now
      well established and its metabolic priming by hyperglycemia could explain the greater
      seriousness of these pathologies in T2D patients due to an exacerbated inflammatory response.
      Currently, there is no human data on the role of NLRP3 inflammasome activation in post-ECC
      inflammatory syndrome. The investigators envision that the extracorporeal circulation (ECC),
      responsible for cellular damage, is accompanied by a release of molecular patterns of DAMPs
      type at the origin of the activation of the NLRP3 inflammasome.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Type 2 diabetics patients
primary purpose: Other
masking: None (Open Label)
measure: Variation in the plasma concentration of cytokines IL-1β and IL18
time frame: 48 hours
description: The variation in the plasma concentration of the two pro-inflammatory cytokines IL-1β and IL18, between a baseline level measured the day before the operating room (D-1) and 24 hours (D1) after cardiac surgery with ECC. The variation in their concentrations is measured between D-1 and D1 in order to assess the inflammatory response occurring in the first hours post ECC, and mediated by the NLRP3 inflammasome.
measure: Compare the plasma levels of IL-1β and IL18
time frame: Compare between Day-1 and Day 7
description: The plasma levels of IL-1β and IL18 will be determined using commercial assay kits (ELISA technique and expressed in pg / mL).
measure: Compare the plasma concentration of mitochondrial (damage-associated molecular patterns) DAMPS
time frame: Compare between Day-1 and Day 7
description: Plasma mitochondrial DNA plasma concentration will be achieved by the real-time polymerase chain reaction (PCR). The results will be expressed in number of copies of DNA per microliter.
measure: Compare the level of activation of the NLRP3 inflammasome in circulating blood monocytes
time frame: Compare between Day-1 and Day 7
description: The level of activation of the NLRP3 inflammasome in circulating blood monocytes, expressed by the number of copies of NLRP3 mRNA measured in quantitative RT-PCR (RT-qPCR) in monocytes isolated from circulating blood.
measure: Compare the plasma concentration of reactive protein C (CRP) the level of activation of the NLRP3 inflammasome in circulating blood monocytes.
time frame: Compare between Day-1 and Day 7
description: CRP is a protein synthesized by the liver whose expression increases during the acute phase of inflammation
arm group label: Type 2 diabetes patients
arm group type: Experimental
description: The variation in the plasma concentration of the two pro-inflammatory cytokines IL-1β and IL18, between a baseline level measured the day before the operating room (D-1) and 24 hours (D1) for TD2 patients after cardiac surgery with extracorporeal circulation .
arm group label: Non-diabetic type 2 patients
arm group type: Active Comparator
description: The variation in the plasma concentration of the two pro-inflammatory cytokines IL-1β and IL18, between a baseline level measured the day before the operating room (D-1) and 24 hours (D1) for non-diabetic type 2 patients after cardiac surgery with extracorporeal circulation
intervention type: Procedure
intervention name: The role of the activation of the NLRP3 inflammasome after cardiac surgery
description: Determine the effect on the inflammatory response post extracorporeal circulation mediated by the NLRP3 inflammasome, in patients after cardiac surgery
arm group label: Non-diabetic type 2 patients
arm group label: Type 2 diabetes patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Martinique
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No