<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/NCT03038373</url>
  </required_header>
  <id_info>
    <org_study_id>RA-2011-014</org_study_id>
    <nct_id>NCT03038373</nct_id>
  </id_info>
  <brief_title>Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery</brief_title>
  <official_title>Elucidating the Mechanism of Remission of Type 2 Diabetes in Morbid Obese Patients After Bariatric Surgery-focused on Beta Cell Function and Insulin Sensitivity Changes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dasman Diabetes Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kuwait University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dasman Diabetes Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes&#xD;
      in the morbid obese patients after laparoscopic sleeve gastrectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study four groups including: Group I - Morbid Obese Diabetics, Group II - Morbid&#xD;
      Obese Non Diabetics, Group III - Lean Diabetics, and Group IV - Lean Non Diabetics will be&#xD;
      studies. The bariatric surgical procedure should include Laparoscopic Sleeve Gastrectomy&#xD;
      (LSG). All participants will be assessed by members of a multidisciplinary obesity team&#xD;
      including a surgeon, endocrinologist, dietician, and nurse specialist who will usually have&#xD;
      input into patient selection.&#xD;
&#xD;
      Briefly the study will be explained to the each participant, and after his/her agreement, the&#xD;
      informed Consent Form will be deliver to him/her for completion and signature. Within a week&#xD;
      before surgery each enrolled participant of group I and II will be subjected to a medical&#xD;
      questionnaire and other routine laboratory analyses before surgery such as fasting glucose,&#xD;
      liver, renal, lipid and coagulation profiles. At this time a Mixed Meal Tolerance Test (MMTT)&#xD;
      will be performed and blood samples will be collected for further analysis as it is described&#xD;
      in the protocol.&#xD;
&#xD;
      Participants in group I and II will be admitted at Dasman Diabetes Institute for post-surgery&#xD;
      follow up, performing MMTT, and donating blood samples on days 07, 15, 30, 60, 90, 180, and&#xD;
      360 post-surgery. Adipose, muscle biopsies, and a sample from remnant surgical tissue from&#xD;
      these participants will be harvested during of the LSG (days 0). Participants in group I will&#xD;
      be asked to monitor their fasting blood glucose level everyday at early morning and the dose&#xD;
      of anti-hyperglycemia medications will be adjusted by the recommendation provided by the&#xD;
      physician member of team. This data will be recorded as their continuous blood glucose&#xD;
      monitoring.&#xD;
&#xD;
      Group III and IV participants, as control groups with no surgical intervention, will be&#xD;
      subjected to the medical questionnaire and other routine laboratory analyses and MMTT in just&#xD;
      one visit.&#xD;
&#xD;
      All demographic and clinical information collected from the participants will be recorded in&#xD;
      the information form identified by identification number (ID number). Only samples from the&#xD;
      cases that do not have any post-surgery related complications or not have any emergency&#xD;
      clinical condition will be used for genomics and proteomics analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2022</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>Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level &lt; 7.0 mmol and HbA1c &lt;6.5%</measure>
    <time_frame>1 year</time_frame>
    <description>Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level &lt; 7.0 mmol and HbA1c &lt;6.5%</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Morbid Obesity</condition>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <description>Morbid Obese Type 2 Diabetics, undergo Laparoscopic Sleeve Gastrectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <description>Morbid Obese Non Diabetics, undergo Laparoscopic Sleeve Gastrectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <description>Lean Diabetics, No surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group IV</arm_group_label>
    <description>Lean Non Diabetics, No surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Sleeve Gastrectomy</intervention_name>
    <description>Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, serum, plasma, peripheral blood mononuclear cell (PBMC), fat tissues, muscle&#xD;
      tissues, remnant surgical tissue.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Group I and II: eligible candidates will be selected from waiting list of the surgeon,&#xD;
        Group III: volunteer lean type 2 diabetics from patient list of Dasman Diabetes Institute&#xD;
        Group IV: Invitation to volunteer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults&#xD;
&#xD;
          -  Type 2 diabetes &lt;5 years&#xD;
&#xD;
          -  male and female,&#xD;
&#xD;
          -  resident of Kuwait,&#xD;
&#xD;
          -  who agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  malignancy,&#xD;
&#xD;
          -  type 1 diabetes,&#xD;
&#xD;
          -  type 2 diabetes with more than 5 years,&#xD;
&#xD;
          -  and history with overt heart and/or kidney failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hossein Arefanian, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dasman Diabetes Institute</affiliation>
  </overall_official>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Obesity, Morbid</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/NCT03038373
org study id: RA-2011-014
nct id: NCT03038373
lead sponsor: 
collaborator: 
has dmc: No
The main aim of this study is to elucidate the mechanism of the remission of type 2 diabetes
      in the morbid obese patients after laparoscopic sleeve gastrectomy.
In this study four groups including: Group I - Morbid Obese Diabetics, Group II - Morbid
      Obese Non Diabetics, Group III - Lean Diabetics, and Group IV - Lean Non Diabetics will be
      studies. The bariatric surgical procedure should include Laparoscopic Sleeve Gastrectomy
      (LSG). All participants will be assessed by members of a multidisciplinary obesity team
      including a surgeon, endocrinologist, dietician, and nurse specialist who will usually have
      input into patient selection.

      Briefly the study will be explained to the each participant, and after his/her agreement, the
      informed Consent Form will be deliver to him/her for completion and signature. Within a week
      before surgery each enrolled participant of group I and II will be subjected to a medical
      questionnaire and other routine laboratory analyses before surgery such as fasting glucose,
      liver, renal, lipid and coagulation profiles. At this time a Mixed Meal Tolerance Test (MMTT)
      will be performed and blood samples will be collected for further analysis as it is described
      in the protocol.

      Participants in group I and II will be admitted at Dasman Diabetes Institute for post-surgery
      follow up, performing MMTT, and donating blood samples on days 07, 15, 30, 60, 90, 180, and
      360 post-surgery. Adipose, muscle biopsies, and a sample from remnant surgical tissue from
      these participants will be harvested during of the LSG (days 0). Participants in group I will
      be asked to monitor their fasting blood glucose level everyday at early morning and the dose
      of anti-hyperglycemia medications will be adjusted by the recommendation provided by the
      physician member of team. This data will be recorded as their continuous blood glucose
      monitoring.

      Group III and IV participants, as control groups with no surgical intervention, will be
      subjected to the medical questionnaire and other routine laboratory analyses and MMTT in just
      one visit.

      All demographic and clinical information collected from the participants will be recorded in
      the information form identified by identification number (ID number). Only samples from the
      cases that do not have any post-surgery related complications or not have any emergency
      clinical condition will be used for genomics and proteomics analysis.
observational model: Case-Control
time perspective: Prospective
measure: Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level < 7.0 mmol and HbA1c <6.5%
time frame: 1 year
description: Evidence of clinically definition of remission of type 2 diabetes by by fasting blood glucose level < 7.0 mmol and HbA1c <6.5%
arm group label: Group I
description: Morbid Obese Type 2 Diabetics, undergo Laparoscopic Sleeve Gastrectomy
arm group label: Group II
description: Morbid Obese Non Diabetics, undergo Laparoscopic Sleeve Gastrectomy
arm group label: Group III
description: Lean Diabetics, No surgery
arm group label: Group IV
description: Lean Non Diabetics, No surgery
intervention type: Procedure
intervention name: Laparoscopic Sleeve Gastrectomy
description: Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.
arm group label: Group I
arm group label: Group II
Whole blood, serum, plasma, peripheral blood mononuclear cell (PBMC), fat tissues, muscle
      tissues, remnant surgical tissue.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hossein Arefanian, PhD
role: Principal Investigator
affiliation: Dasman Diabetes Institute
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Obesity, Morbid
sharing ipd: No