<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/NCT02183935</url>
  </required_header>
  <id_info>
    <org_study_id>EB-AD-39/03/14</org_study_id>
    <nct_id>NCT02183935</nct_id>
  </id_info>
  <brief_title>Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner</brief_title>
  <official_title>Treatment of Morbidly Obese Adolescent With a Duodena-jejunal Liner - a Study on Efficacy and Pathophysiologic Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Centre Ljubljana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity and its complications have a significant effect on morbidity and mortality in these&#xD;
      subjects. Especially at risk are subjects with extremely increased BMI (above 99th percentile&#xD;
      for age and gender in adolescents). In these subjects classical treatment with diet and&#xD;
      cognitive therapy has a limited effect. Bariatric procedures, at the moment, are the only&#xD;
      feasible therapeutic possibility.&#xD;
&#xD;
      Bariatric procedures are based on several principles; restrictive, malabsorptive and&#xD;
      combined. They can be surgical or endoscopic. The later are used in subjects that do not&#xD;
      qualify for surgical procedures that decline them or are used before a planed definite&#xD;
      bariatric procedure.&#xD;
&#xD;
      Duodena-jejunal liner (DJL) is an endoscopic tool, that is efficiently and safely used to&#xD;
      decrease body weight and ameliorated obesity complications, especially those associated with&#xD;
      diabetic state.&#xD;
&#xD;
      Aims of the study are:&#xD;
&#xD;
        -  To determine (short and long-term) efficacy of DJL in decreasing body weight in&#xD;
           adolescents.&#xD;
&#xD;
        -  To determine (short and long-term) efficacy of DJL in ameliorating complications of&#xD;
           morbid obesity - abnormal glucose metabolism, dislipidemia, altered adipokine secretion&#xD;
           pattern, altered secretion pattern of gastrointestinal hormones in adolescents.&#xD;
&#xD;
        -  To visualize functional alternations in the selected central nervous system regions&#xD;
           associated with appetite regulation upon insertion of DJL.&#xD;
&#xD;
        -  To evaluate psychological outcomes; change in emotional and behaviour problems, in body&#xD;
           image, in eating disorder symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 20, 2018</completion_date>
  <primary_completion_date type="Actual">December 10, 2018</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in BMI (BMI SDS)</measure>
    <time_frame>12 and 24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in basal and stimulated glucose and insulin levels</measure>
    <time_frame>12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cholesterol levels</measure>
    <time_frame>12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in selected gut hormones</measure>
    <time_frame>12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in selected adipokine and inflammatory cytokines levels</measure>
    <time_frame>12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in activity of selected appetite-associated central nervous system regions.</measure>
    <time_frame>12 and 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in emotional and behaviour problems, body image and eating disorder symptoms</measure>
    <time_frame>12 and 24 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety profile of DJL in adolescents.</measure>
    <time_frame>12 months</time_frame>
    <description>Number of participants with adverse events (pain, nausea, vomiting, bleeding, gastrointestinal obstruction) and number of adverse events will be used to measure safety and tolerability of the investigated device in adolescents.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Lifestyle counseling, metformin</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Age, gender and BMI matched controls will be managed by lifestyle counseling and metformin if indicated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Duodeno - jejunal liner</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Duodeno-jejunal liner (Endobarrier) will be implanted for the duration of 12 months. During this time subjects will be regularly monitored for investigated parameters. In addition, subjects will be carefully monitored upon device removal for additional 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Duodena-jejunal liner</intervention_name>
    <arm_group_label>Duodeno - jejunal liner</arm_group_label>
    <other_name>Endobarrier</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects estimated to fully comply with study protocol and have signed an informed&#xD;
             consent form.&#xD;
&#xD;
          -  Age &gt; 15 years.&#xD;
&#xD;
          -  BMI ≥ 99. percentile for age and gender.&#xD;
&#xD;
          -  Inefficient conservative measures (of at least 6 months duration) to decrease body&#xD;
             weight (characterized as a decrease in BMI &gt; 10 %).&#xD;
&#xD;
          -  Documented negative pregnancy test in women of childbearing potential.&#xD;
&#xD;
          -  Women of childbearing potential agree to remain on contraceptives for the duration of&#xD;
             their trial participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous GI surgery that could potentially affect the ability to place sleeve or&#xD;
             affect the function of the implant.&#xD;
&#xD;
          -  Subjects with congenital or acquired anomalies of the GI tract which in the opinion of&#xD;
             the investigator, may impair implantation of the EndoBarrier device.&#xD;
&#xD;
          -  Subjects who had gastrooesophageal reflucs disease..&#xD;
&#xD;
          -  Known abnormal pathologies or conditions of the gastrointestinal tract, including&#xD;
             ulcers or Crohn's disease, upper gastro-intestinal bleeding conditions.&#xD;
&#xD;
          -  Coagulopathy defined as Hgb &lt;10g/dl and platelet &lt; 100,000/ml or diagnosis of other&#xD;
             severe coagulopathy like hemophilia.&#xD;
&#xD;
          -  Any documented history of acute or chronic pancreatitis.&#xD;
&#xD;
          -  Subjects requiring regular antithrombotic therapy (i.e. anticoagulant or antiplatelet&#xD;
             agent).&#xD;
&#xD;
          -  Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune&#xD;
             connective tissue disorder.&#xD;
&#xD;
          -  Subject is or has been enrolled in another investigational study within 6 months of&#xD;
             participation into the EndoBarrier study.&#xD;
&#xD;
          -  Subjects who are mentally retarded or emotionally unstable.&#xD;
&#xD;
          -  Subjects who are pregnant or were breastfeeding.&#xD;
&#xD;
          -  Subjects with an abnormal laboratory or ECG abnormality which the investigators deems&#xD;
             clinically significant and makes the patient a poor candidate for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tadej Battelino, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMC Ljubljana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMC Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <reference>
    <citation>Escalona A, Pimentel F, Sharp A, Becerra P, Slako M, Turiel D, Munoz R, Bambs C, Guzman S, Ibanez L, Gersin K. Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal-jejunal bypass liner. Ann Surg. 2012 Jun;255(6):1080-5. doi: 10.1097/SLA.0b013e31825498c4.</citation>
    <PMID>22534421</PMID>
  </reference>
  <reference>
    <citation>de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvao Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Junior AB, Mancini MC, Halpern A, Cecconello I. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther. 2012 Feb;14(2):183-9. doi: 10.1089/dia.2011.0152. Epub 2011 Sep 20.</citation>
    <PMID>21932999</PMID>
  </reference>
  <reference>
    <citation>de Moura EG, Orso IR, Martins BC, Lopes GS, de Oliveira SL, Galvao-Neto Mdos P, Mancini MC, Santo MA, Sakai P, Ramos AC, Garrido-Junior AB, Halpern A, Cecconello I. Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner. Obes Surg. 2011 Jul;21(7):941-7. doi: 10.1007/s11695-011-0387-0.</citation>
    <PMID>21442376</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</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 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Tadej Battelino</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Diabetes</keyword>
  <keyword>Metabolic syndrome</keyword>
  <keyword>Gut hormones</keyword>
  <keyword>Adipokines</keyword>
  <keyword>Appetite</keyword>
  <keyword>Adolescent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</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/NCT02183935
org study id: EB-AD-39/03/14
nct id: NCT02183935
lead sponsor: 
has dmc: No
Obesity and its complications have a significant effect on morbidity and mortality in these
      subjects. Especially at risk are subjects with extremely increased BMI (above 99th percentile
      for age and gender in adolescents). In these subjects classical treatment with diet and
      cognitive therapy has a limited effect. Bariatric procedures, at the moment, are the only
      feasible therapeutic possibility.

      Bariatric procedures are based on several principles; restrictive, malabsorptive and
      combined. They can be surgical or endoscopic. The later are used in subjects that do not
      qualify for surgical procedures that decline them or are used before a planed definite
      bariatric procedure.

      Duodena-jejunal liner (DJL) is an endoscopic tool, that is efficiently and safely used to
      decrease body weight and ameliorated obesity complications, especially those associated with
      diabetic state.

      Aims of the study are:

        -  To determine (short and long-term) efficacy of DJL in decreasing body weight in
           adolescents.

        -  To determine (short and long-term) efficacy of DJL in ameliorating complications of
           morbid obesity - abnormal glucose metabolism, dislipidemia, altered adipokine secretion
           pattern, altered secretion pattern of gastrointestinal hormones in adolescents.

        -  To visualize functional alternations in the selected central nervous system regions
           associated with appetite regulation upon insertion of DJL.

        -  To evaluate psychological outcomes; change in emotional and behaviour problems, in body
           image, in eating disorder symptoms.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in BMI (BMI SDS)
time frame: 12 and 24 months
measure: Change in basal and stimulated glucose and insulin levels
time frame: 12 and 24 months
measure: Change in cholesterol levels
time frame: 12 and 24 months
measure: Change in selected gut hormones
time frame: 12 and 24 months
measure: Change in selected adipokine and inflammatory cytokines levels
time frame: 12 and 24 months
measure: Change in activity of selected appetite-associated central nervous system regions.
time frame: 12 and 24 months
measure: Change in emotional and behaviour problems, body image and eating disorder symptoms
time frame: 12 and 24 months
measure: Safety profile of DJL in adolescents.
time frame: 12 months
description: Number of participants with adverse events (pain, nausea, vomiting, bleeding, gastrointestinal obstruction) and number of adverse events will be used to measure safety and tolerability of the investigated device in adolescents.
arm group label: Lifestyle counseling, metformin
arm group type: No Intervention
description: Age, gender and BMI matched controls will be managed by lifestyle counseling and metformin if indicated.
arm group label: Duodeno - jejunal liner
arm group type: Active Comparator
description: Duodeno-jejunal liner (Endobarrier) will be implanted for the duration of 12 months. During this time subjects will be regularly monitored for investigated parameters. In addition, subjects will be carefully monitored upon device removal for additional 12 months.
intervention type: Device
intervention name: Duodena-jejunal liner
arm group label: Duodeno - jejunal liner
other name: Endobarrier
criteria: 
gender: All
minimum age: 16 Years
maximum age: 20 Years
healthy volunteers: No
last name: Tadej Battelino, MD, PhD
role: Principal Investigator
affiliation: UMC Ljubljana
facility: 
country: Slovenia
citation: Escalona A, Pimentel F, Sharp A, Becerra P, Slako M, Turiel D, Munoz R, Bambs C, Guzman S, Ibanez L, Gersin K. Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal-jejunal bypass liner. Ann Surg. 2012 Jun;255(6):1080-5. doi: 10.1097/SLA.0b013e31825498c4.
PMID: 22534421
citation: de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvao Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Junior AB, Mancini MC, Halpern A, Cecconello I. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther. 2012 Feb;14(2):183-9. doi: 10.1089/dia.2011.0152. Epub 2011 Sep 20.
PMID: 21932999
citation: de Moura EG, Orso IR, Martins BC, Lopes GS, de Oliveira SL, Galvao-Neto Mdos P, Mancini MC, Santo MA, Sakai P, Ramos AC, Garrido-Junior AB, Halpern A, Cecconello I. Improvement of insulin resistance and reduction of cardiovascular risk among obese patients with type 2 diabetes with the duodenojejunal bypass liner. Obes Surg. 2011 Jul;21(7):941-7. doi: 10.1007/s11695-011-0387-0.
PMID: 21442376
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Tadej Battelino
investigator title: Prof. Dr.
mesh term: Metabolic Syndrome