<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/NCT02985853</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00003207</org_study_id>
    <secondary_id>U01DK066557</secondary_id>
    <secondary_id>U01DK066555-08</secondary_id>
    <nct_id>NCT02985853</nct_id>
  </id_info>
  <brief_title>Longitudinal Assessment of Bariatric Surgery Sub-Study</brief_title>
  <acronym>LABS-3</acronym>
  <official_title>Longitudinal Assessment of Bariatric Surgery Sub-Study: A Prospective, Longitudinal Cohort Study of the Mechanisms for Improvement of Type 2 Diabetes Following Bariatric Surgery (LABS-3 DIABETES)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</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>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this project is to examine the physical mechanisms that contribute to&#xD;
      improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of&#xD;
      bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this project is to examine the physiological mechanisms that contribute to&#xD;
      improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass&#xD;
      Roux-en-Y bariatric surgery (GBP). The central hypotheses are: 1) that surgical changes in&#xD;
      the anatomy of nutrient absorption achieved by GBP change incretin hormone secretion which in&#xD;
      turn improves pancreatic islet function; and 2) that improvement in insulin secretion induced&#xD;
      by the changes in incretin function, together with improvement in insulin resistance induced&#xD;
      by weight loss, normalize glucose homeostasis in type 2 DM.&#xD;
&#xD;
      Funds are not available to pay for the surgery for patients, only to address research&#xD;
      questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 2008</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Actual">February 15, 2021</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>Weight</measure>
    <time_frame>Up to 72 months</time_frame>
    <description>Weight measurements will take place at every visit, up to 72 months after bariatric surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Capillary Blood Glucose</measure>
    <time_frame>Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.</time_frame>
    <description>Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.</description>
  </primary_outcome>
  <enrollment type="Actual">39</enrollment>
  <condition>Obesity</condition>
  <condition>Diabetes Mellitus</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum, plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Study participants will be selected from the LABS-2 cohort at participating LABS clinical&#xD;
        centers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are at least 18 years of age and undergo bariatric surgery by a LABS&#xD;
             certified surgeon.&#xD;
&#xD;
          -  Enrollment in LABS-1 or LABS-2.&#xD;
&#xD;
          -  Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is&#xD;
             treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see&#xD;
             appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less&#xD;
             than or equal to 180 mg/dL. This will be one group.&#xD;
&#xD;
          -  Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the&#xD;
             second group.&#xD;
&#xD;
          -  Adequate IV access.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Informed consent not obtained.&#xD;
&#xD;
          -  Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose&#xD;
             greater than 180 mg/dL.&#xD;
&#xD;
          -  Creatinine greater than 1.7.&#xD;
&#xD;
          -  Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e.&#xD;
             geographically inaccessible for study visits) or unable to communicate with local&#xD;
             study staff.&#xD;
&#xD;
          -  Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 14, 2022</last_update_submitted>
  <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Jonathan Purnell</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT02985853
org study id: IRB00003207
secondary id: U01DK066557
secondary id: U01DK066555-08
nct id: NCT02985853
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this project is to examine the physical mechanisms that contribute to
      improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of
      bariatric surgery.
The goal of this project is to examine the physiological mechanisms that contribute to
      improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass
      Roux-en-Y bariatric surgery (GBP). The central hypotheses are: 1) that surgical changes in
      the anatomy of nutrient absorption achieved by GBP change incretin hormone secretion which in
      turn improves pancreatic islet function; and 2) that improvement in insulin secretion induced
      by the changes in incretin function, together with improvement in insulin resistance induced
      by weight loss, normalize glucose homeostasis in type 2 DM.

      Funds are not available to pay for the surgery for patients, only to address research
      questions.
observational model: Case-Control
time perspective: Prospective
measure: Weight
time frame: Up to 72 months
description: Weight measurements will take place at every visit, up to 72 months after bariatric surgery.
measure: Capillary Blood Glucose
time frame: Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.
description: Capillary Blood Glucose (CBG) will be measured at multiple protocol-defined intervals during visits, up to 72 months after the bariatric surgical procedure.
serum, plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Jonathan Purnell
investigator title: Professor
sharing ipd: No