<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/NCT03238794</url>
  </required_header>
  <id_info>
    <org_study_id>16-008664</org_study_id>
    <secondary_id>K23DK114460</secondary_id>
    <nct_id>NCT03238794</nct_id>
  </id_info>
  <brief_title>Bariatric Surgery Versus Diet Alone in the Bile Acid Pathway and Weight Loss</brief_title>
  <official_title>Effect of Weight Loss Through RYGB Versus Weight Loss Through Caloric Restriction on the Bile Acid Pathway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
      It is unknown whether the bile acid pathway reacts differently to weight loss resulting from&#xD;
      Roux-En-Y Gastric Bypass (RYGB) surgery than weight loss resulting from caloric restriction&#xD;
      alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be placed into two groups. The Roux-En-Y Gastric Bypass (RYGB) group will&#xD;
      consist of participants who will have elected to have RYGB at the Mayo Clinic Bariatric&#xD;
      Center of Excellence. The Diet group will have a low-calorie diet prescribed by a registered&#xD;
      dietitian. Both groups will collect stool from every bowel movement 2 days before presenting&#xD;
      for baseline testing. Both group participants will present for baseline testing after an&#xD;
      overnight fast and before intervention (RYGB or low calorie diet). Participants will consume&#xD;
      a standard breakfast provided by study staff and blood samples will be collected at -15, 0,&#xD;
      15, 30,45,60,90,120,150,180,210,240,300,360 minutes. Appetite and satiation ratings will be&#xD;
      recorded via questionnaires during that day every 15 minutes for the first 90 minutes, then&#xD;
      every 30 minutes. Participants will repeat this regimen again after losing 7% of their body&#xD;
      weight after having RYGB or low calorie diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 17, 2019</start_date>
  <completion_date type="Anticipated">January 11, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 11, 2024</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Bile Acid (BA) excretion</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Total Fecal BA excretion change measured in mcmoles/48 hours</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Roux-En-Y Gastric Bypass (RYGB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will have elected to have RYGB surgery per standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-calorie Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will have a low-calorie diet prescribed by a registered dietitian.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Roux-En-Y Gastric Bypass</intervention_name>
    <description>Food will be consumed as directed by their doctor as standard of care. A food log will be completed the week before visits 3 and 5.</description>
    <arm_group_label>Roux-En-Y Gastric Bypass (RYGB)</arm_group_label>
    <other_name>RYGB</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-calorie Diet</intervention_name>
    <description>Food will be consumed as Week one will be liquid 400 to 500 kcal/day, weeks 2,3, and 4 will consist of 500-600 kcal/day of pureed food, weeks 5-8 will consist of 600-800 kcal/day of mechanical-soft food, weeks 9-12 will consist of 800 to 1000 kcal/day of soft foods, and the remainder of the study participants will be given 1000 to 1200 kcal/day of regular food.</description>
    <arm_group_label>Low-calorie Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women of childbearing potential will have negative pregnancy tests within 48 hours of&#xD;
             enrolment.&#xD;
&#xD;
          -  BMI: ≥ 40&#xD;
&#xD;
          -  Individuals who have elected to have RYGB at the Mayo Clinic Bariatric Center of&#xD;
             Excellence, and individuals with a BMI ≥40 who are otherwise healthy with controlled&#xD;
             cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or&#xD;
             endocrine disorders. The RYGB participants will be invited to participate when their&#xD;
             surgery is scheduled at the Mayo Clinic Bariatric Center of Excellence.&#xD;
&#xD;
          -  The non-RYGB participants (BMI ≥40) will be otherwise healthy individuals with no&#xD;
             unstable psychiatric disease and no unstable cardiac, pulmonary, gastrointestinal,&#xD;
             hepatic, renal, hematological, neurological, or endocrine disorders.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of abdominal surgery including cholecystectomy and other than appendectomy,&#xD;
             Caesarian section or tubal ligation.&#xD;
&#xD;
          -  Positive history of chronic gastrointestinal diseases, or systemic disease that could&#xD;
             affect gastrointestinal motility, or use of medications that may alter&#xD;
             gastrointestinal motility, appetite or absorption, e.g., orlistat, phentermine.&#xD;
&#xD;
          -  Significant untreated psychiatric dysfunction based upon screening with the Hospital&#xD;
             Anxiety and Depression Inventory (HAD), a self-administered alcoholism screening test&#xD;
             (AUDIT-C) and the Questionnaire on Eating and Weight Patterns (binge eating disorders&#xD;
             and bulimia). If such a dysfunction is identified by a depression or anxiety score &gt;11&#xD;
             or difficulties with substance or eating disorders, the participant will be excluded&#xD;
             and given a referral letter to his/her primary care doctor for further appraisal and&#xD;
             follow-up. The AUDIT-C is a 3-item alcohol screening questionnaire that reliably&#xD;
             identifies participants who are hazardous alcohol drinkers or have active alcohol use&#xD;
             disorders. In men, a score of 4 or more is above the recommended limits will be&#xD;
             reviewed by study personnel. In women, a score of 3 or more is above the recommended&#xD;
             limits will be reviewed by study personnel. However when the points are above&#xD;
             recommended limits, the provider will review the patient's alcohol intake over the&#xD;
             past few months to confirm accuracy and determine study eligibility.&#xD;
&#xD;
          -  Any acute or chronic condition or other disease that, in the opinion of the&#xD;
             Investigator, would limit the subject's ability to complete and/or participate in this&#xD;
             clinical study.Participant activities:&#xD;
&#xD;
          -  If recruited for the investigation participants will be asked to refrain from donating&#xD;
             blood; refrain from participating in other research studies; avoid taking any&#xD;
             additional over the counter or prescription medications or herbal supplements that&#xD;
             have not been reviewed and approved by the physician or the study coordinator until&#xD;
             the study has been completed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andres J Acosta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Andres J. Acosta, M.D., Ph.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Body Mass Index</keyword>
  <keyword>gastric</keyword>
  <keyword>bypass</keyword>
  <keyword>bariatric surgery</keyword>
  <keyword>bile acid</keyword>
  <keyword>weight loss</keyword>
  <keyword>diet</keyword>
  <keyword>low calorie</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</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/NCT03238794
org study id: 16-008664
secondary id: K23DK114460
nct id: NCT03238794
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is unknown whether the bile acid pathway reacts differently to weight loss resulting from
      Roux-En-Y Gastric Bypass (RYGB) surgery than weight loss resulting from caloric restriction
      alone.
Participants will be placed into two groups. The Roux-En-Y Gastric Bypass (RYGB) group will
      consist of participants who will have elected to have RYGB at the Mayo Clinic Bariatric
      Center of Excellence. The Diet group will have a low-calorie diet prescribed by a registered
      dietitian. Both groups will collect stool from every bowel movement 2 days before presenting
      for baseline testing. Both group participants will present for baseline testing after an
      overnight fast and before intervention (RYGB or low calorie diet). Participants will consume
      a standard breakfast provided by study staff and blood samples will be collected at -15, 0,
      15, 30,45,60,90,120,150,180,210,240,300,360 minutes. Appetite and satiation ratings will be
      recorded via questionnaires during that day every 15 minutes for the first 90 minutes, then
      every 30 minutes. Participants will repeat this regimen again after losing 7% of their body
      weight after having RYGB or low calorie diet.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Bile Acid (BA) excretion
time frame: baseline, 12 weeks
description: Total Fecal BA excretion change measured in mcmoles/48 hours
arm group label: Roux-En-Y Gastric Bypass (RYGB)
arm group type: Active Comparator
description: Participants will have elected to have RYGB surgery per standard of care.
arm group label: Low-calorie Diet
arm group type: Active Comparator
description: Participants will have a low-calorie diet prescribed by a registered dietitian.
intervention type: Procedure
intervention name: Roux-En-Y Gastric Bypass
description: Food will be consumed as directed by their doctor as standard of care. A food log will be completed the week before visits 3 and 5.
arm group label: Roux-En-Y Gastric Bypass (RYGB)
other name: RYGB
intervention type: Other
intervention name: Low-calorie Diet
description: Food will be consumed as Week one will be liquid 400 to 500 kcal/day, weeks 2,3, and 4 will consist of 500-600 kcal/day of pureed food, weeks 5-8 will consist of 600-800 kcal/day of mechanical-soft food, weeks 9-12 will consist of 800 to 1000 kcal/day of soft foods, and the remainder of the study participants will be given 1000 to 1200 kcal/day of regular food.
arm group label: Low-calorie Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Andres J Acosta, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Andres J. Acosta, M.D., Ph.D.
investigator title: Principal Investigator
mesh term: Weight Loss
sharing ipd: No