<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/NCT02202902</url>
  </required_header>
  <id_info>
    <org_study_id>AOR12017</org_study_id>
    <secondary_id>2013-A01023-42</secondary_id>
    <nct_id>NCT02202902</nct_id>
  </id_info>
  <brief_title>Cardiac Steatosis in Cushing's Syndrome</brief_title>
  <acronym>CORTICOEUR</acronym>
  <official_title>Evaluation of Cardiac Steatosis in Cushing's Syndrome. A 1H-Magnetic Resonance Spectroscopy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims at evaluating the myocardial triglyceride content and cardiac structure and&#xD;
      function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in&#xD;
      patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched&#xD;
      healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients&#xD;
      compared to healthy subjects present with excess lipid storage in cardiac myocytes,&#xD;
      reversible upon correction of hypercortisolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite skeletal muscle atrophy, Cushing's syndrome patients have an increased Left&#xD;
      Ventricular mass, reversible upon correction of the hypercortisolism. This may be due to&#xD;
      cardiac steatosis, previously demonstrated in patients with diabetes mellitus. This study&#xD;
      aims at evaluating the myocardial triglyceride content and cardiac structure and function,&#xD;
      using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging (CMRI), in&#xD;
      patients with Cushing's syndrome and in age-, sex- and BMI-matched healthy volunteers. The&#xD;
      patients will be stratified into two groups in function of the presence or absence of&#xD;
      diabetes mellitus or impaired glucose and will be evaluated twice: before and 6 months after&#xD;
      efficient treatment of Cushing's syndrome. We make the hypothesis that Cushing's syndrome&#xD;
      patients compared to healthy subjects have excess lipid storage in cardiac myocytes&#xD;
      irrespectively of the glucose homeostasis status, and that this lipid content will decrease&#xD;
      after the correction of hypercortisolism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio</measure>
    <time_frame>Assessed twice in patients - before and 6 months after treatment - and once in volunteers</time_frame>
    <description>Intramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Left Ventricular intramyocardial fatt fraction (Dixon)</measure>
    <time_frame>Assessed twice in patients - before and 6 months after treatment - and once in volunteers</time_frame>
    <description>In/Out of Phase Imaging (Dixon)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subcutaneous and visceral abdominal fatt</measure>
    <time_frame>Assessed twice in patients - before and 6 months after treatment - and once in volunteers</time_frame>
    <description>ISubcutaneous and visceral abdominal fat masses were determined from abdominal axial images at the L3 to L4 level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac morphology and function</measure>
    <time_frame>Assessed twice in patients - before and 6 months after treatment - and once in volunteers</time_frame>
    <description>LV mass index, LA, LV and Right Ventricular (RV) ejection fractions and LV and RV stroke volumes assessed by Cardiac Magnetic Resonance Imaging (CMRI)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Endocrine System Disease</condition>
  <condition>Cardiovascular Imaging</condition>
  <arm_group>
    <arm_group_label>Group 1 : 1H magnetic resonance spectroscopy and CMRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 : 1H magnetic resonance spectroscopy and CMRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2: Cushing's syndrome patients with normal glucose intolerance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 : 1H magnetic resonance spectroscopy and CMRI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>age-, sex- and BMI-matched healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>1H magnetic resonance spectroscopy and CMRI</intervention_name>
    <description>Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before and 6 month after treatment</description>
    <arm_group_label>Group 1 : 1H magnetic resonance spectroscopy and CMRI</arm_group_label>
    <arm_group_label>Group 2 : 1H magnetic resonance spectroscopy and CMRI</arm_group_label>
    <other_name>Before and after Treatment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>1H magnetic resonance spectroscopy and CMRI</intervention_name>
    <description>Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before treatment</description>
    <arm_group_label>Group 3 : 1H magnetic resonance spectroscopy and CMRI</arm_group_label>
    <other_name>Once</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  group 1 and 2: patients with overt Cushing's syndrome, with 24-hour urinary free&#xD;
             cortisol excretion over the two fold of the upper limit of the normal, with (group 1)&#xD;
             or without (group 2) diabetes mellitus or glucose intolerance&#xD;
&#xD;
          -  group 3: healthy volunteers matched for age, sex and BMI with the patients of the&#xD;
             group 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication of MRI&#xD;
&#xD;
          -  hypersensitivity to gadolinium&#xD;
&#xD;
          -  acute myocardial ischemia&#xD;
&#xD;
          -  renal insufficiency (creatinin clearance 30 mL/min/l,73m2)&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe CHANSON, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HP, Bicêtre Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philippe CHANSON, MD, PhD</last_name>
    <phone>+33 (0)1 45 21 37 05</phone>
    <email>philippe.chanson@bct.aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Peter KAMENICKY, MD</last_name>
    <phone>+33 (0)1 45 21 37 06</phone>
    <email>peter.kamenicky@bct.aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AP-HP, Bicêtre Hospital</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter KAMENICKY, MD</last_name>
      <phone>+33 (0)1 45 21 37 06</phone>
      <email>peter.kamenicky@bct.aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>September 28, 2016</last_update_submitted>
  <last_update_submitted_qc>September 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cushing's syndrome</keyword>
  <keyword>cardiac steatosis</keyword>
  <keyword>intramyocardial triglyceride content</keyword>
  <keyword>1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging</keyword>
  <keyword>Left Ventricularly hypertrophy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Cushing Syndrome</mesh_term>
    <mesh_term>Endocrine System Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT02202902
org study id: AOR12017
secondary id: 2013-A01023-42
nct id: NCT02202902
lead sponsor: 
has dmc: No
This study aims at evaluating the myocardial triglyceride content and cardiac structure and
      function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in
      patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched
      healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients
      compared to healthy subjects present with excess lipid storage in cardiac myocytes,
      reversible upon correction of hypercortisolism.
Despite skeletal muscle atrophy, Cushing's syndrome patients have an increased Left
      Ventricular mass, reversible upon correction of the hypercortisolism. This may be due to
      cardiac steatosis, previously demonstrated in patients with diabetes mellitus. This study
      aims at evaluating the myocardial triglyceride content and cardiac structure and function,
      using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging (CMRI), in
      patients with Cushing's syndrome and in age-, sex- and BMI-matched healthy volunteers. The
      patients will be stratified into two groups in function of the presence or absence of
      diabetes mellitus or impaired glucose and will be evaluated twice: before and 6 months after
      efficient treatment of Cushing's syndrome. We make the hypothesis that Cushing's syndrome
      patients compared to healthy subjects have excess lipid storage in cardiac myocytes
      irrespectively of the glucose homeostasis status, and that this lipid content will decrease
      after the correction of hypercortisolism.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio
time frame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
description: Intramyocardial triglyceride content will be assessed by 1H magnetic resonance spectroscopy
measure: Left Ventricular intramyocardial fatt fraction (Dixon)
time frame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
description: In/Out of Phase Imaging (Dixon)
measure: Subcutaneous and visceral abdominal fatt
time frame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
description: ISubcutaneous and visceral abdominal fat masses were determined from abdominal axial images at the L3 to L4 level
measure: Cardiac morphology and function
time frame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
description: LV mass index, LA, LV and Right Ventricular (RV) ejection fractions and LV and RV stroke volumes assessed by Cardiac Magnetic Resonance Imaging (CMRI)
arm group label: Group 1 : 1H magnetic resonance spectroscopy and CMRI
arm group type: Experimental
description: Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance
arm group label: Group 2 : 1H magnetic resonance spectroscopy and CMRI
arm group type: Experimental
description: Group 2: Cushing's syndrome patients with normal glucose intolerance
arm group label: Group 3 : 1H magnetic resonance spectroscopy and CMRI
arm group type: Experimental
description: age-, sex- and BMI-matched healthy volunteers
intervention type: Other
intervention name: 1H magnetic resonance spectroscopy and CMRI
description: Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before and 6 month after treatment
arm group label: Group 1 : 1H magnetic resonance spectroscopy and CMRI
arm group label: Group 2 : 1H magnetic resonance spectroscopy and CMRI
other name: Before and after Treatment
intervention type: Other
intervention name: 1H magnetic resonance spectroscopy and CMRI
description: Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before treatment
arm group label: Group 3 : 1H magnetic resonance spectroscopy and CMRI
other name: Once
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philippe CHANSON, MD, PhD
role: Principal Investigator
affiliation: AP-HP, Bicêtre Hospital
last name: Philippe CHANSON, MD, PhD
phone: +33 (0)1 45 21 37 05
email: philippe.chanson@bct.aphp.fr
last name: Peter KAMENICKY, MD
phone: +33 (0)1 45 21 37 06
email: peter.kamenicky@bct.aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Fatty Liver
mesh term: Cushing Syndrome
mesh term: Endocrine System Diseases