<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/NCT01724060</url>
  </required_header>
  <id_info>
    <org_study_id>FPS</org_study_id>
    <nct_id>NCT01724060</nct_id>
  </id_info>
  <brief_title>Effects of Obesity Treatments on Food Preferences and Metabolism</brief_title>
  <acronym>FPS</acronym>
  <official_title>The Effects of Current Treatments of Obesity on Food Preferences, Gut Hormones, Bile Acids and Hepatic Glucose Output in Humans.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden&#xD;
      both for patients and health systems alike. The surgical and medical treatments available for&#xD;
      these conditions have improved significantly in the last two decades. The investigators do&#xD;
      not however know how these treatments compare to each other and how they act in the body to&#xD;
      cause weight loss and diabetes improvements. The studies of this experiment are complementary&#xD;
      to each other. They aim to answer related questions and will allow us to study how these&#xD;
      treatments work and eventually develop safer and more effective therapies for obesity and&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to investigate the effects of obesity surgical procedures and&#xD;
      incretin therapies on food preferences, satiety, gut hormones, bile acids and hepatic glucose&#xD;
      output in overweight and obese patients.&#xD;
&#xD;
      As part of routine care these patients will be seen by a dietician/diabetes specialist nurse&#xD;
      (DSN) before and after intervention. Patients will be asked to prospectively complete food&#xD;
      diaries on three consecutive days which are representative of their usual dietary intake. The&#xD;
      first food diary will be completed three months to two weeks pre intervention. Another four&#xD;
      food diaries will be completed post intervention: at one, three months, 6 months and one&#xD;
      year. Total energy intake and macronutrient composition comparisons pre and post intervention&#xD;
      will form the basis of our analysis.&#xD;
&#xD;
      20 patients in each group will undergo more detailed measurements of food intake, hunger,&#xD;
      satiety, gut hormones and bile acids. The research protocol will be the similar to that&#xD;
      previously published by the Department of Metabolic Medicine, Imperial College, London.&#xD;
      Participants will be fasted for 12 hours overnight and will attend for the study on 5&#xD;
      occasions. On each occasion venous blood samples will be taken and visual analogue scores&#xD;
      will be measured over a 3 hour period using previously published methodology Samples or&#xD;
      sample containers will be anonymised before collection but will be traceable back to the&#xD;
      individual patients. Urine will be collected once. A qualified medical doctor will insert a&#xD;
      venepuncture cannula into the arm of the patient and 5ml blood will be withdrawn at baseline,&#xD;
      15, 30, 60, 90, 120, 150 and 180 minutes following ingestion of a standard 400kcal meal as&#xD;
      below.&#xD;
&#xD;
      Ten patients in each group (different from those taking part in the meal studies) will&#xD;
      undergo measurements of hepatic glucose output/insulin resistance through euglycaemic&#xD;
      hyperinsulinaemic clamps (Metabolic Study). To ensure that acute caloric restriction does not&#xD;
      affect insulin sensitivity, patients will be on a low calorie liquid diet for 4-14 days and&#xD;
      3-7 days after intervention to ensure that their weight is stable throughout the study. This&#xD;
      diet is nutritious and contains all appropriate macronutrients. Such diets are frequently&#xD;
      used as part of pre-obesity interventions to reduce weight and risk. Patients will provide&#xD;
      the investigators with a detailed food diary of their food consumption for this period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Energy Intake From Baseline</measure>
    <time_frame>Change at 12 months</time_frame>
    <description>The difference in total calories consumption between baseline and 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Appetite Ratings From Baseline</measure>
    <time_frame>Change 12 months</time_frame>
    <description>Visual Analogues difference between baseline and follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Metabolites From Baseline</measure>
    <time_frame>Change at 12 months</time_frame>
    <description>Blood samples difference between baseline and follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hepatic Insulin Resistance From Baseline</measure>
    <time_frame>Change at 1 week after intervention</time_frame>
    <description>Insulin clamps difference between baseline and follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Macronutrient Composition From Baseline</measure>
    <time_frame>Change at 12 months</time_frame>
    <description>Macronutrients difference between baseline and follow up</description>
  </secondary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Obesity</condition>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Gastric bypass</arm_group_label>
    <description>Patients due for gastric bypass surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gastric banding</arm_group_label>
    <description>Patients due for gastric banding</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleeve gastrectomy</arm_group_label>
    <description>Patients due for sleeve gastrectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endobarrier</arm_group_label>
    <description>Patients due to undergo endoscopic Endobarrier insertion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exenatide</arm_group_label>
    <description>Patients due to be commenced on Exenatide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liraglutide</arm_group_label>
    <description>Patients due to be commenced on Liraglutide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lifestyle</arm_group_label>
    <description>Patients due to be commenced on a lifestyle intervention programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elective surgery or endoscopy</arm_group_label>
    <description>Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Human plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from the community or hospital care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with overweight and/or obesity (BMI ≥30 Kg/m2) who are eligible for&#xD;
             obesity treatment based on NICE guidance or that are having non bariatric surgery or&#xD;
             endoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carel W le Roux, MRCP PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial Weight Centre</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <results_first_submitted>February 17, 2020</results_first_submitted>
  <results_first_submitted_qc>March 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 31, 2020</results_first_posted>
  <last_update_submitted>March 19, 2020</last_update_submitted>
  <last_update_submitted_qc>March 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 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>Obesity</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 12, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT01724060/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>There were no pre assignments requirements</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Gastric Bypass</title>
          <description>Patients due for gastric bypass surgery</description>
        </group>
        <group group_id="P2">
          <title>Gastric Banding</title>
          <description>Patients due for gastric banding</description>
        </group>
        <group group_id="P3">
          <title>Sleeve Gastrectomy</title>
          <description>Patients due for sleeve gastrectomy</description>
        </group>
        <group group_id="P4">
          <title>Endobarrier</title>
          <description>Patients due to undergo endoscopic Endobarrier insertion</description>
        </group>
        <group group_id="P5">
          <title>Exenatide</title>
          <description>Patients due to be commenced on Exenatide</description>
        </group>
        <group group_id="P6">
          <title>Liraglutide</title>
          <description>Patients due to be commenced on Liraglutide</description>
        </group>
        <group group_id="P7">
          <title>Lifestyle</title>
          <description>Patients due to be commenced on a lifestyle intervention programme</description>
        </group>
        <group group_id="P8">
          <title>Elective Surgery or Endoscopy</title>
          <description>Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="10"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="10"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients attending obesity clinic from living in a multinational city such as London.</population>
      <group_list>
        <group group_id="B1">
          <title>Gastric Bypass</title>
          <description>Patients due for gastric bypass surgery</description>
        </group>
        <group group_id="B2">
          <title>Gastric Banding</title>
          <description>Patients due for gastric banding</description>
        </group>
        <group group_id="B3">
          <title>Sleeve Gastrectomy</title>
          <description>Patients due for sleeve gastrectomy</description>
        </group>
        <group group_id="B4">
          <title>Endobarrier</title>
          <description>Patients due to undergo endoscopic Endobarrier insertion</description>
        </group>
        <group group_id="B5">
          <title>Exenatide</title>
          <description>Patients due to be commenced on Exenatide</description>
        </group>
        <group group_id="B6">
          <title>Liraglutide</title>
          <description>Patients due to be commenced on Liraglutide</description>
        </group>
        <group group_id="B7">
          <title>Lifestyle</title>
          <description>Patients due to be commenced on a lifestyle intervention programme</description>
        </group>
        <group group_id="B8">
          <title>Elective Surgery or Endoscopy</title>
          <description>Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="10"/>
            <count group_id="B6" value="10"/>
            <count group_id="B7" value="10"/>
            <count group_id="B8" value="10"/>
            <count group_id="B9" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42" spread="12"/>
                    <measurement group_id="B2" value="40" spread="14"/>
                    <measurement group_id="B3" value="44" spread="9"/>
                    <measurement group_id="B4" value="43" spread="7"/>
                    <measurement group_id="B5" value="44" spread="8"/>
                    <measurement group_id="B6" value="41" spread="7"/>
                    <measurement group_id="B7" value="43" spread="13"/>
                    <measurement group_id="B8" value="40" spread="15"/>
                    <measurement group_id="B9" value="42" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="10"/>
                    <measurement group_id="B9" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Food Intake</title>
          <units>kcal</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1505" spread="205"/>
                    <measurement group_id="B2" value="1490" spread="218"/>
                    <measurement group_id="B3" value="1482" spread="162"/>
                    <measurement group_id="B4" value="1511" spread="197"/>
                    <measurement group_id="B5" value="1503" spread="222"/>
                    <measurement group_id="B6" value="1420" spread="183"/>
                    <measurement group_id="B7" value="1471" spread="193"/>
                    <measurement group_id="B8" value="1453" spread="211"/>
                    <measurement group_id="B9" value="1503" spread="198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Energy Intake From Baseline</title>
        <description>The difference in total calories consumption between baseline and 12 months</description>
        <time_frame>Change at 12 months</time_frame>
        <population>Patients that had specific obesity interventions.</population>
        <group_list>
          <group group_id="O1">
            <title>Gastric Bypass</title>
            <description>Patients due for gastric bypass surgery</description>
          </group>
          <group group_id="O2">
            <title>Gastric Banding</title>
            <description>Patients due for gastric banding</description>
          </group>
          <group group_id="O3">
            <title>Sleeve Gastrectomy</title>
            <description>Patients due for sleeve gastrectomy</description>
          </group>
          <group group_id="O4">
            <title>Endobarrier</title>
            <description>Patients due to undergo endoscopic Endobarrier insertion</description>
          </group>
          <group group_id="O5">
            <title>Exenatide</title>
            <description>Patients due to be commenced on Exenatide</description>
          </group>
          <group group_id="O6">
            <title>Liraglutide</title>
            <description>Patients due to be commenced on Liraglutide</description>
          </group>
          <group group_id="O7">
            <title>Lifestyle</title>
            <description>Patients due to be commenced on a lifestyle intervention programme</description>
          </group>
          <group group_id="O8">
            <title>Elective Surgery or Endoscopy</title>
            <description>Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Energy Intake From Baseline</title>
          <description>The difference in total calories consumption between baseline and 12 months</description>
          <population>Patients that had specific obesity interventions.</population>
          <units>kcal</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="500" spread="55"/>
                    <measurement group_id="O2" value="310" spread="76"/>
                    <measurement group_id="O3" value="482" spread="69"/>
                    <measurement group_id="O4" value="5" spread="105"/>
                    <measurement group_id="O5" value="27" spread="92"/>
                    <measurement group_id="O6" value="103" spread="74"/>
                    <measurement group_id="O7" value="11" spread="129"/>
                    <measurement group_id="O8" value="15" spread="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Appetite Ratings From Baseline</title>
        <description>Visual Analogues difference between baseline and follow up</description>
        <time_frame>Change 12 months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Metabolites From Baseline</title>
        <description>Blood samples difference between baseline and follow up</description>
        <time_frame>Change at 12 months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hepatic Insulin Resistance From Baseline</title>
        <description>Insulin clamps difference between baseline and follow up</description>
        <time_frame>Change at 1 week after intervention</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Macronutrient Composition From Baseline</title>
        <description>Macronutrients difference between baseline and follow up</description>
        <time_frame>Change at 12 months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>No difference</desc>
      <group_list>
        <group group_id="E1">
          <title>Gastric Bypass</title>
          <description>Patients due for gastric bypass surgery.</description>
        </group>
        <group group_id="E2">
          <title>Gastric Banding</title>
          <description>Patients due for gastric banding.</description>
        </group>
        <group group_id="E3">
          <title>Sleeve Gastrectomy</title>
          <description>Patients due for sleeve gastrectomy.</description>
        </group>
        <group group_id="E4">
          <title>EndoBarrier</title>
          <description>Patients due to undergo endoscopic Endobarrier insertion.</description>
        </group>
        <group group_id="E5">
          <title>Exenatide</title>
          <description>Patients due to be commenced on Exenatide.</description>
        </group>
        <group group_id="E6">
          <title>Liraglutide</title>
          <description>Patients due to be commenced on Liraglutide.</description>
        </group>
        <group group_id="E7">
          <title>Lifestyle</title>
          <description>Patients due to be commenced on a lifestyle intervention programme.</description>
        </group>
        <group group_id="E8">
          <title>Elective Surgery or Endoscopy</title>
          <description>Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy. No adverse events recorded.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was limited by different treatment modalities being compared such as endobarrier, gastric bypass and medication</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Carel le Roux</name_or_title>
      <organization>Imperial College</organization>
      <phone>07970719453</phone>
      <email>c.leroux@imperial.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01724060
org study id: FPS
nct id: NCT01724060
lead sponsor: 
has dmc: Yes
Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden
      both for patients and health systems alike. The surgical and medical treatments available for
      these conditions have improved significantly in the last two decades. The investigators do
      not however know how these treatments compare to each other and how they act in the body to
      cause weight loss and diabetes improvements. The studies of this experiment are complementary
      to each other. They aim to answer related questions and will allow us to study how these
      treatments work and eventually develop safer and more effective therapies for obesity and
      diabetes.
The objective of this study is to investigate the effects of obesity surgical procedures and
      incretin therapies on food preferences, satiety, gut hormones, bile acids and hepatic glucose
      output in overweight and obese patients.

      As part of routine care these patients will be seen by a dietician/diabetes specialist nurse
      (DSN) before and after intervention. Patients will be asked to prospectively complete food
      diaries on three consecutive days which are representative of their usual dietary intake. The
      first food diary will be completed three months to two weeks pre intervention. Another four
      food diaries will be completed post intervention: at one, three months, 6 months and one
      year. Total energy intake and macronutrient composition comparisons pre and post intervention
      will form the basis of our analysis.

      20 patients in each group will undergo more detailed measurements of food intake, hunger,
      satiety, gut hormones and bile acids. The research protocol will be the similar to that
      previously published by the Department of Metabolic Medicine, Imperial College, London.
      Participants will be fasted for 12 hours overnight and will attend for the study on 5
      occasions. On each occasion venous blood samples will be taken and visual analogue scores
      will be measured over a 3 hour period using previously published methodology Samples or
      sample containers will be anonymised before collection but will be traceable back to the
      individual patients. Urine will be collected once. A qualified medical doctor will insert a
      venepuncture cannula into the arm of the patient and 5ml blood will be withdrawn at baseline,
      15, 30, 60, 90, 120, 150 and 180 minutes following ingestion of a standard 400kcal meal as
      below.

      Ten patients in each group (different from those taking part in the meal studies) will
      undergo measurements of hepatic glucose output/insulin resistance through euglycaemic
      hyperinsulinaemic clamps (Metabolic Study). To ensure that acute caloric restriction does not
      affect insulin sensitivity, patients will be on a low calorie liquid diet for 4-14 days and
      3-7 days after intervention to ensure that their weight is stable throughout the study. This
      diet is nutritious and contains all appropriate macronutrients. Such diets are frequently
      used as part of pre-obesity interventions to reduce weight and risk. Patients will provide
      the investigators with a detailed food diary of their food consumption for this period.
observational model: Case-Control
time perspective: Prospective
measure: Change in Energy Intake From Baseline
time frame: Change at 12 months
description: The difference in total calories consumption between baseline and 12 months
measure: Change in Appetite Ratings From Baseline
time frame: Change 12 months
description: Visual Analogues difference between baseline and follow up
measure: Change in Metabolites From Baseline
time frame: Change at 12 months
description: Blood samples difference between baseline and follow up
measure: Change in Hepatic Insulin Resistance From Baseline
time frame: Change at 1 week after intervention
description: Insulin clamps difference between baseline and follow up
measure: Change in Macronutrient Composition From Baseline
time frame: Change at 12 months
description: Macronutrients difference between baseline and follow up
arm group label: Gastric bypass
description: Patients due for gastric bypass surgery
arm group label: Gastric banding
description: Patients due for gastric banding
arm group label: Sleeve gastrectomy
description: Patients due for sleeve gastrectomy
arm group label: Endobarrier
description: Patients due to undergo endoscopic Endobarrier insertion
arm group label: Exenatide
description: Patients due to be commenced on Exenatide
arm group label: Liraglutide
description: Patients due to be commenced on Liraglutide
arm group label: Lifestyle
description: Patients due to be commenced on a lifestyle intervention programme
arm group label: Elective surgery or endoscopy
description: Patients due to have non bariatric surgery (i.e. cholecystectomy) or an elective diagnostic endoscopy
Human plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carel W le Roux, MRCP PhD
role: Principal Investigator
affiliation: Imperial College London
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Obesity
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was limited by different treatment modalities being compared such as endobarrier, gastric bypass and medication
point of contact: 