<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/NCT03024879</url>
  </required_header>
  <id_info>
    <org_study_id>MotilinAndFoodIntake</org_study_id>
    <nct_id>NCT03024879</nct_id>
  </id_info>
  <brief_title>The Effect of Motilin on the Frequency and Amount of Food Intake</brief_title>
  <official_title>Influence of Erythromycin on ad Libitum Food Intake and the Evaluation of Motilin in Food Timing in Healthy Volunteers and Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, the investigators aimed at evaluating the role of motilin in the regulation of&#xD;
      food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy volunteers&#xD;
      and is significantly increased in obese patients. Its role in food intake regulation might&#xD;
      contribute to the pathogenesis of obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>March 2014</start_date>
  <primary_completion_date type="Anticipated">March 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo</measure>
    <time_frame>Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of food intake correlated with motilin plasma levels</measure>
    <time_frame>Assessment will be done over a period of 5 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Healthy</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Erythromycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>a saline solution of 100 ml will be administered intravenously over a period of 20 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erythromycin</intervention_name>
    <arm_group_label>Erythromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &lt; 30 kg/m² for lean volunteers&#xD;
&#xD;
          -  BMI &gt; 30 kg/m² for obese volunteers&#xD;
&#xD;
          -  Subject is capable and willing to give informed consent&#xD;
&#xD;
          -  Female volunteers of child bearing potential must use oral, injected or implanted&#xD;
             hormonal methods of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female volunteer is pregnant or breastfeeding&#xD;
&#xD;
          -  GI diseases, major abdominal surgery&#xD;
&#xD;
          -  Major psychiatric illnesses&#xD;
&#xD;
          -  Volunteers that use drugs affecting the GI tract or the central nervous system&#xD;
&#xD;
          -  Volunteers suffering from endocrine diseases such as diabetes, Cushing's disease,&#xD;
             Addison's disease, hypothalamic tumor&#xD;
&#xD;
          -  Volunteers that have undergone surgical procedure for weight loss&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Tack, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>May 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Motilin</keyword>
  <keyword>Erythromycin</keyword>
  <keyword>Food intake</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erythromycin</mesh_term>
    <mesh_term>Erythromycin Estolate</mesh_term>
    <mesh_term>Erythromycin Ethylsuccinate</mesh_term>
    <mesh_term>Erythromycin stearate</mesh_term>
  </intervention_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/NCT03024879
org study id: MotilinAndFoodIntake
nct id: NCT03024879
lead sponsor: 
has dmc: No
In this study, the investigators aimed at evaluating the role of motilin in the regulation of
      food intake. Motilin, a gastrointestinal hormone, is a hunger signal in healthy volunteers
      and is significantly increased in obese patients. Its role in food intake regulation might
      contribute to the pathogenesis of obesity.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change in food intake, assessed by caloric intake, after intravenous administration of erythromycin compared to placebo
time frame: Caloric intake will be assessed 1 hour after the start of infusion and the start of ad libitum food intake
measure: Frequency of food intake correlated with motilin plasma levels
time frame: Assessment will be done over a period of 5 hours
arm group label: Erythromycin
arm group type: Active Comparator
description: 40 mg of erythromycin will be administered intravenously over a period of 20 min in a saline solution of 100 ml
arm group label: Placebo
arm group type: Placebo Comparator
description: a saline solution of 100 ml will be administered intravenously over a period of 20 min
intervention type: Drug
intervention name: Erythromycin
arm group label: Erythromycin
intervention type: Drug
intervention name: Saline
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Tack, Prof
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
responsible party type: Sponsor
mesh term: Erythromycin
mesh term: Erythromycin Estolate
mesh term: Erythromycin Ethylsuccinate
mesh term: Erythromycin stearate
sharing ipd: No