<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/NCT03006016</url>
  </required_header>
  <id_info>
    <org_study_id>15-API-03</org_study_id>
    <nct_id>NCT03006016</nct_id>
  </id_info>
  <brief_title>Preoperative Omega-3 Polyunsaturated Fatty Acids in Morbidly Obese to Reduce Liver Volume and Steatosis</brief_title>
  <acronym>Omegobese</acronym>
  <official_title>Impact of Preoperative 4-week Supplementation With Omega-3 Polyunsaturated Fatty Acids on Liver Volume and Steatosis to Facilitate Bariatric Surgery in Morbdly Obese Patients : the &quot; Omegaobese Study &quot;.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Nice</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Nice</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>
      Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the&#xD;
      hiatal region during bariatric surgery. The doctors made a preliminary prospective study that&#xD;
      showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction&#xD;
      resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on&#xD;
      ultrasounds.&#xD;
&#xD;
      The aim of this study is to determine whether a 4-week preoperative course with omega-3&#xD;
      without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume&#xD;
      and its fat content, rendering thus surgery easier.&#xD;
&#xD;
      The primary end point is the reduction of the volume of the left liver lobe as measured by&#xD;
      magnetic resonance imaging.&#xD;
&#xD;
      Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver&#xD;
      injuries during surgery, and duration of surgery, the evolution of liver tests as well as the&#xD;
      correlation between preoperative MRI data and intraoperative liver biopsy for the&#xD;
      quantification of liver steatosis.&#xD;
&#xD;
      Study design: This is an interventional, prospective, multicentric, randomized, double&#xD;
      blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to&#xD;
      bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute&#xD;
      Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients&#xD;
      in 12 months.&#xD;
&#xD;
      Study time schedule: At the time of the enrollment visit two visits are scheduled, the first&#xD;
      before the beginning of the study and the last at the end. Surgery is scheduled no more than&#xD;
      7 days after the end of the treatment. At time of these two visits a clinical examination is&#xD;
      performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL&#xD;
      cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive protein)&#xD;
      and a MRI to evaluate the volume and the fat content of the liver. At time of surgery&#xD;
      duration of surgery and any eventual liver injury are recorded and a liver biopsy is&#xD;
      performed.&#xD;
&#xD;
      The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a&#xD;
      reduction in the volume of the left liver lobe of 20 %.&#xD;
&#xD;
      Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results in&#xD;
      a significant reduction of liver volume and steatosis before bariatric surgery, it may be&#xD;
      recommended as a systematic preoperative treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2017</start_date>
  <completion_date type="Actual">August 7, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The volume of the left liver lobe</measure>
    <time_frame>4 weeks</time_frame>
    <description>Reduction of the volume of the left liver lobe as measured by magnetic resonance imaging between the beginning of the study and its end (4 weeks)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The whole liver volume</measure>
    <time_frame>4 weeks</time_frame>
    <description>Reduction of the whole liver volume (as measured on MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The liver injuries</measure>
    <time_frame>4 weeks</time_frame>
    <description>liver injuries during surgery (surgeon report)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>the liver steatosis</measure>
    <time_frame>4 weeks</time_frame>
    <description>Reduction of the whole liver steatosis (as measured on MRI)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Morbid Obesity D009765</condition>
  <arm_group>
    <arm_group_label>Omega 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will take Omega 3 before intervention 4-week course of 1.500 Mg/ day without caloric restriction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The patient will take placebo before intervention 4-week course of 1.500 Mg/ day without caloric restriction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omega-3 Fatty Acid</intervention_name>
    <description>The enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group.</description>
    <arm_group_label>Omega 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 - 60 years&#xD;
&#xD;
          -  Karnofsky Index de &gt; 70&#xD;
&#xD;
          -  BMI &gt; 35 kg/m2 associated with metabolic syndrome define by three or more of the&#xD;
             following: waistline that measures at least 80 centimeters for european women and 94&#xD;
             centimeters for european men; High triglyceride level less than 1.5 g/l or specific&#xD;
             medications; Reduced high-density lipoprotein (HDL) cholesterol less than 1.04 mmol/L&#xD;
             in men or less than 1.3 mmol/L in women; Increased blood pressure 130/85 millimeters&#xD;
             of mercury (mm Hg) or higher or specific medications; Elevated fasting blood sugar 100&#xD;
             mg/dL (5.6 mmol/L) or higher or specific médications.&#xD;
&#xD;
          -  Failure of previous medical treatment of morbid obesity well conducted by a&#xD;
             multidisciplinary team for at least 6 months.&#xD;
&#xD;
          -  Multidisciplinary team agreement for bariatric surgery&#xD;
&#xD;
          -  Patients affiliated to the French Health Care System (Sécurité Sociale)&#xD;
&#xD;
          -  Patients having signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to MRI (pace-maker, metallic foreign bodies, claustrophobia)&#xD;
&#xD;
          -  Psychiatric contraindications to bariatric surgery&#xD;
&#xD;
          -  Anesthesiology contraindications to surgery&#xD;
&#xD;
          -  Progressive malignancies&#xD;
&#xD;
          -  Chronic alcoholism (&gt;30 gr/day)&#xD;
&#xD;
          -  Uncontrolled sepsis&#xD;
&#xD;
          -  History of liver disease&#xD;
&#xD;
          -  Renal failure (Cockroft &lt;30ml/min)&#xD;
&#xD;
          -  Long term treatment with steroids&#xD;
&#xD;
          -  Regular assumption of alimentary complements enriched with proteins and/or amino&#xD;
             acids)&#xD;
&#xD;
          -  Pregnancy (pregnancy test will be done before surgery in fertile women)&#xD;
&#xD;
          -  History of bariatric surgery of supramesocolic surgery rendering the access to the&#xD;
             hiatal region difficult.&#xD;
&#xD;
          -  Forseeable difficulies in completing follow-up&#xD;
&#xD;
          -  Patients under judicial protection&#xD;
&#xD;
          -  Patients unable to understand or put in practice medical prescription as omega-3 oral&#xD;
             supplementation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>IANNELLI Antonio, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Nice</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Nice - Chirurgie Digestive- Hôpital Archet</name>
      <address>
        <city>Nice</city>
        <state>Alpes-maritimes</state>
        <zip>06200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier - Chirurgie digestive</name>
      <address>
        <city>Montpellier</city>
        <state>Languedoc - Roussillon</state>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>February 18, 2022</last_update_submitted>
  <last_update_submitted_qc>February 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2022</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>Obesity, Morbid</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/NCT03006016
org study id: 15-API-03
nct id: NCT03006016
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hepatomegaly is common in the morbidly obese patients and it may hamper the access to the
      hiatal region during bariatric surgery. The doctors made a preliminary prospective study that
      showed that a preoperative 4-week course of 1.500 Mg/ day without caloric restriction
      resulted in a 20 % reduction in the volume of the left liver lobe (segment 2 and 3) on
      ultrasounds.

      The aim of this study is to determine whether a 4-week preoperative course with omega-3
      without caloric restriction (1650 mg of omega-3 / day for 4 weeks) may reduce liver volume
      and its fat content, rendering thus surgery easier.

      The primary end point is the reduction of the volume of the left liver lobe as measured by
      magnetic resonance imaging.

      Secondary end points are: the reduction of the whole liver volume, liver steatosis, liver
      injuries during surgery, and duration of surgery, the evolution of liver tests as well as the
      correlation between preoperative MRI data and intraoperative liver biopsy for the
      quantification of liver steatosis.

      Study design: This is an interventional, prospective, multicentric, randomized, double
      blinded clinical trial. Morbidly obese patients with metabolic syndrome candidate to
      bariatric surgery fulfilling criteria for bariatric surgery as established by the Haute
      Autorité de Santé are elegible for the study. Number of subjects to be enrolled: 44 patients
      in 12 months.

      Study time schedule: At the time of the enrollment visit two visits are scheduled, the first
      before the beginning of the study and the last at the end. Surgery is scheduled no more than
      7 days after the end of the treatment. At time of these two visits a clinical examination is
      performed avec calculation of the BMI, blood tests (ASAT, ALAT; GGT, total, HDL and LDL
      cholesterol, triglycerides, glycemia, C-peptide, HbA1c, insulin, HOMA-IR, C reactive protein)
      and a MRI to evaluate the volume and the fat content of the liver. At time of surgery
      duration of surgery and any eventual liver injury are recorded and a liver biopsy is
      performed.

      The hypothesis is that, as shown by the preliminary study, the omega-3, will result in a
      reduction in the volume of the left liver lobe of 20 %.

      Conclusion: If a 4-week preoperative course of omega-3 without caloric restriction results in
      a significant reduction of liver volume and steatosis before bariatric surgery, it may be
      recommended as a systematic preoperative treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: The volume of the left liver lobe
time frame: 4 weeks
description: Reduction of the volume of the left liver lobe as measured by magnetic resonance imaging between the beginning of the study and its end (4 weeks)
measure: The whole liver volume
time frame: 4 weeks
description: Reduction of the whole liver volume (as measured on MRI)
measure: The liver injuries
time frame: 4 weeks
description: liver injuries during surgery (surgeon report)
measure: the liver steatosis
time frame: 4 weeks
description: Reduction of the whole liver steatosis (as measured on MRI)
arm group label: Omega 3
arm group type: Experimental
description: The patient will take Omega 3 before intervention 4-week course of 1.500 Mg/ day without caloric restriction
arm group label: Placebo
arm group type: Placebo Comparator
description: The patient will take placebo before intervention 4-week course of 1.500 Mg/ day without caloric restriction
intervention type: Drug
intervention name: Omega-3 Fatty Acid
description: The enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group.
arm group label: Omega 3
intervention type: Other
intervention name: Placebo
description: The enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: IANNELLI Antonio, PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Nice
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Obesity, Morbid
sharing ipd: No