<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/NCT01700686</url>
  </required_header>
  <id_info>
    <org_study_id>GBPK</org_study_id>
    <nct_id>NCT01700686</nct_id>
  </id_info>
  <brief_title>The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.</brief_title>
  <official_title>The Effect of Gastric Bypass Surgery on Gut Hormones Related to Bone Remodeling and Intestinal Growth.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Copenhagen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose is to explore the link between the gut and the bones by investigating&#xD;
      meal stimulated changes in the blood level of a number of hormones and markers related to&#xD;
      intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric&#xD;
      bypass). The hormones will be measured in blood samples taken before and after surgery. The&#xD;
      results are compared with changes in body weight and body composition as measured by DEXA&#xD;
      scanning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Meal stimulated changes in gut hormones and bone markers.</measure>
    <time_frame>Before surgery and 4 weeks and 6 months after surgery.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in bone mass and body composition.</measure>
    <time_frame>Before surgery and 6 months after surgery.</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Obesity</condition>
  <condition>Bone Loss</condition>
  <arm_group>
    <arm_group_label>Obese subjects</arm_group_label>
    <description>Meal test and dexa scan</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Meal test and dexa scan</intervention_name>
    <description>Body composition is determined by whole body deca scan and bone mineral density is determined dy dexa scans of the lumbar spine and the proximal femur.</description>
    <arm_group_label>Obese subjects</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma and serum samples are retained.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects are recruited from The Bariatric Clinic, The Hospital of Roskilde-Koege, The&#xD;
        University of Copenhagen.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caucasians fulfilling the criteria for laparoscopic gastric bypass.&#xD;
&#xD;
          -  BMI&gt;40kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Chronic inflammatory bowel disease&#xD;
&#xD;
          -  Major psychiatric disorder&#xD;
&#xD;
          -  Drug abuse&#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>Bolette Hartmann, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital of Roskilde-Koege, The University of Copenhagen</name>
      <address>
        <city>Koege</city>
        <zip>DK-4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 2, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>December 16, 2014</last_update_submitted>
  <last_update_submitted_qc>December 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Copenhagen</investigator_affiliation>
    <investigator_full_name>Bolette Hartmann</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <!-- 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/NCT01700686
org study id: GBPK
nct id: NCT01700686
lead sponsor: 
collaborator: 
has dmc: No
The overall purpose is to explore the link between the gut and the bones by investigating
      meal stimulated changes in the blood level of a number of hormones and markers related to
      intestinal growth and bone turnover in patients undergoing surgery for obesity (gastric
      bypass). The hormones will be measured in blood samples taken before and after surgery. The
      results are compared with changes in body weight and body composition as measured by DEXA
      scanning.
observational model: Case-Only
time perspective: Prospective
measure: Meal stimulated changes in gut hormones and bone markers.
time frame: Before surgery and 4 weeks and 6 months after surgery.
measure: Changes in bone mass and body composition.
time frame: Before surgery and 6 months after surgery.
arm group label: Obese subjects
description: Meal test and dexa scan
intervention type: Other
intervention name: Meal test and dexa scan
description: Body composition is determined by whole body deca scan and bone mineral density is determined dy dexa scans of the lumbar spine and the proximal femur.
arm group label: Obese subjects
Plasma and serum samples are retained.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bolette Hartmann, PhD
role: Principal Investigator
affiliation: University of Copenhagen
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Copenhagen
investigator full name: Bolette Hartmann
investigator title: PhD