<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/NCT04451759</url>
  </required_header>
  <id_info>
    <org_study_id>2019-45</org_study_id>
    <nct_id>NCT04451759</nct_id>
  </id_info>
  <brief_title>Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia</brief_title>
  <acronym>HYPOTHALNET</acronym>
  <official_title>Exploration by UHF MRI of Hypothalamic Networks Associated to Feeding in Obesity and Anorexia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</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>
      Food intake is a motivated behaviour that consists of seeking, selecting and ingesting&#xD;
      nutritional resources from the environment. Its main function is therefore, depending on&#xD;
      these conditions, to ensure the supply, in adequate quantities, of the energy and biochemical&#xD;
      substrates necessary for the proper functioning and need of the body. Thus, in addition to&#xD;
      maintaining the body's fat mass level stable, dietary behaviour is part of the energy&#xD;
      homeostasis system and is thus regulated and maintained by the central nervous system.&#xD;
&#xD;
      Although diet regulation involves several brain regions, the way in which these different&#xD;
      regions communicate with each other and influence each other to orchestrate appropriate&#xD;
      eating behaviour is not yet fully characterized. Among the structures of this network, the&#xD;
      hypothalamus, a small structure (less than 1 cm3 in humans) composed of several nuclei such&#xD;
      as the lateral hypothalamus, the arched nucleus or the lateral tuberal nucleus plays a&#xD;
      crucial role.&#xD;
&#xD;
      The investigators propose to use ultra high field (7T) magnetic resonance imaging equiping&#xD;
      the CEMEREM (CHU Timone, APHM, Marseille) to better characterize the role of this crucial&#xD;
      small structure in food intake networks in order to better understand the impact of these&#xD;
      structural and functional disorders observed in patients with anorexia nervosa and obesity&#xD;
      compared to a control population without eating behaviour disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 25, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 15, 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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MRI exploration conducted at 7T</measure>
    <time_frame>2 years</time_frame>
    <description>Mapping of MRI parameters of 4 sub-regions of the hypothalamus, in order to determine whether the sensitivity of quantitative T1 to 7T imaging at very high resolution can reveal microstructure variations in the 4 sub-regions of the hypothalamus in patients suffering from obesity or anorexia nervosa compared to a control population without eating disorders.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Eating Disorders</condition>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Anorexia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Obesity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI exploration</intervention_name>
    <description>ultra high field (7T) magnetic resonance imaging</description>
    <arm_group_label>Anorexia</arm_group_label>
    <arm_group_label>Obesity</arm_group_label>
    <arm_group_label>healthy controls</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No depression (HADS and BECK scores)&#xD;
&#xD;
          -  No contraindication to 7T MRI&#xD;
&#xD;
          -  Subject with with social insurance&#xD;
&#xD;
          -  Subject who has signed the informed consent&#xD;
&#xD;
        For obese patients&#xD;
&#xD;
          -  Body mass index &gt; 30kg/m2&#xD;
&#xD;
          -  Body diameter &lt; 60cm (compatible with 7T MR scanner tube)&#xD;
&#xD;
        For anorexic patients&#xD;
&#xD;
          -  mental anorexia according to DMS-V&#xD;
&#xD;
          -  Body mass index &lt; 17kg/m2&#xD;
&#xD;
        For healthy controls&#xD;
&#xD;
          -  18.5kg/m2&lt;Body mass index &lt; 25kg/m2&#xD;
&#xD;
          -  no feeding behavioral disturbance (SCOFF and EAT 26)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or parturiente woman&#xD;
&#xD;
          -  subject with other neurological or neuropsychiatric diseases&#xD;
&#xD;
          -  subject with addiction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Olivier ARNAUD</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maxime Guye, MD</last_name>
    <email>maxime.guye@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maxime Guye, MD</last_name>
      <email>maxime.guye@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</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>Anorexia</mesh_term>
    <mesh_term>Feeding and Eating Disorders</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/NCT04451759
org study id: 2019-45
nct id: NCT04451759
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Food intake is a motivated behaviour that consists of seeking, selecting and ingesting
      nutritional resources from the environment. Its main function is therefore, depending on
      these conditions, to ensure the supply, in adequate quantities, of the energy and biochemical
      substrates necessary for the proper functioning and need of the body. Thus, in addition to
      maintaining the body's fat mass level stable, dietary behaviour is part of the energy
      homeostasis system and is thus regulated and maintained by the central nervous system.

      Although diet regulation involves several brain regions, the way in which these different
      regions communicate with each other and influence each other to orchestrate appropriate
      eating behaviour is not yet fully characterized. Among the structures of this network, the
      hypothalamus, a small structure (less than 1 cm3 in humans) composed of several nuclei such
      as the lateral hypothalamus, the arched nucleus or the lateral tuberal nucleus plays a
      crucial role.

      The investigators propose to use ultra high field (7T) magnetic resonance imaging equiping
      the CEMEREM (CHU Timone, APHM, Marseille) to better characterize the role of this crucial
      small structure in food intake networks in order to better understand the impact of these
      structural and functional disorders observed in patients with anorexia nervosa and obesity
      compared to a control population without eating behaviour disorders.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: MRI exploration conducted at 7T
time frame: 2 years
description: Mapping of MRI parameters of 4 sub-regions of the hypothalamus, in order to determine whether the sensitivity of quantitative T1 to 7T imaging at very high resolution can reveal microstructure variations in the 4 sub-regions of the hypothalamus in patients suffering from obesity or anorexia nervosa compared to a control population without eating disorders.
arm group label: healthy controls
arm group type: Active Comparator
arm group label: Anorexia
arm group type: Experimental
arm group label: Obesity
arm group type: Experimental
intervention type: Other
intervention name: MRI exploration
description: ultra high field (7T) magnetic resonance imaging
arm group label: Anorexia
arm group label: Obesity
arm group label: healthy controls
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean Olivier ARNAUD
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Maxime Guye, MD
email: maxime.guye@ap-hm.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Feeding and Eating Disorders
sharing ipd: No