<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/NCT02996071</url>
  </required_header>
  <id_info>
    <org_study_id>2016_10/16</org_study_id>
    <nct_id>NCT02996071</nct_id>
  </id_info>
  <brief_title>May Preoperative Waist to Height Ratio Predict Postoperative Weight Loss in Bariatric Patients?</brief_title>
  <official_title>May Preoperative Waist to Height Ratio Predict Postoperative Weight Loss in Bariatric Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bariatric surgery is an effective method for treatment of obesity. Sleeve gastrectomy is one&#xD;
      of surgical methods and became popular in recent years. Weight loss rates after bariatric&#xD;
      surgery differs among patients. The exact reason of this difference stays unclear. age,&#xD;
      nationality, difference between body composition and type of surgery may be in concern. waist&#xD;
      to height ratio has become popular recent years as an indicator of cardiomethabolic status.&#xD;
      in this study, investigation of the effect of waist to height ratio differences of patients&#xD;
      on weight loss following laparoscopic sleeve gastrectomy as a bariatric surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Waist to height raito is the major determinator of patients and will be noted in every&#xD;
      patient who will fulfil the eligibility criteras defined below and undergo laparoscopic&#xD;
      sleeve gastrectomy. demographic data, BMI, body lipid composition, lean body weight also will&#xD;
      be noted. all patients will undergo standardized laparoscopic sleeve gastrectomy operation.&#xD;
      patients will be follow up during first, third, sixth and one year periods. all parameters&#xD;
      noted preoperatively will be measured and noted again. possible statistical difference will&#xD;
      be calculated statistically and a cut off value will be seeked.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight loss rates</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall complications</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Bariatric Surgery Candidate</condition>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>low waist to height ratio</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laparoscopic sleeve gastrectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high waist to height ratio</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>laparoscopic sleeve gastrectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic sleeve gastrectomy</intervention_name>
    <description>a sleeve gastrectomy operation that is performed laparoscopically.</description>
    <arm_group_label>high waist to height ratio</arm_group_label>
    <arm_group_label>low waist to height ratio</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years old&#xD;
&#xD;
          -  BMI&gt;40 kg/m2&#xD;
&#xD;
          -  Sleeve gastrectomy operation planned patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 or 2 diabetes mellitus&#xD;
&#xD;
          -  osteoarticular pathology that may restrict postoperative regular physical activity.&#xD;
&#xD;
          -  apparent mental or psychological disorder that may affect postoperative&#xD;
             recommendations&#xD;
&#xD;
          -  refusal of informed consent for this study&#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>Huseyin K Bektasoglu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Huseyin K Bektasoglu, MD</last_name>
    <phone>+902124531700</phone>
    <email>hkbektasoglu@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bezmialem Vakif University</name>
      <address>
        <city>Istanbul</city>
        <zip>34090</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huseyin K Bektasoglu, MD</last_name>
      <phone>+902124531700</phone>
      <phone_ext>2450</phone_ext>
      <email>hkbektasoglu@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Lutfullah Baskoy, MD</last_name>
      <phone>+902124531700</phone>
      <phone_ext>2452</phone_ext>
      <email>mdbaskoy@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</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, Morbid</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02996071
org study id: 2016_10/16
nct id: NCT02996071
lead sponsor: 
has dmc: Yes
Bariatric surgery is an effective method for treatment of obesity. Sleeve gastrectomy is one
      of surgical methods and became popular in recent years. Weight loss rates after bariatric
      surgery differs among patients. The exact reason of this difference stays unclear. age,
      nationality, difference between body composition and type of surgery may be in concern. waist
      to height ratio has become popular recent years as an indicator of cardiomethabolic status.
      in this study, investigation of the effect of waist to height ratio differences of patients
      on weight loss following laparoscopic sleeve gastrectomy as a bariatric surgery.
Waist to height raito is the major determinator of patients and will be noted in every
      patient who will fulfil the eligibility criteras defined below and undergo laparoscopic
      sleeve gastrectomy. demographic data, BMI, body lipid composition, lean body weight also will
      be noted. all patients will undergo standardized laparoscopic sleeve gastrectomy operation.
      patients will be follow up during first, third, sixth and one year periods. all parameters
      noted preoperatively will be measured and noted again. possible statistical difference will
      be calculated statistically and a cut off value will be seeked.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: weight loss rates
time frame: 6 months
measure: overall complications
time frame: 1 month
arm group label: low waist to height ratio
arm group type: Active Comparator
description: laparoscopic sleeve gastrectomy
arm group label: high waist to height ratio
arm group type: Active Comparator
description: laparoscopic sleeve gastrectomy
intervention type: Procedure
intervention name: laparoscopic sleeve gastrectomy
description: a sleeve gastrectomy operation that is performed laparoscopically.
arm group label: high waist to height ratio
arm group label: low waist to height ratio
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Huseyin K Bektasoglu, MD
role: Principal Investigator
affiliation: Bezmialem Vakif University
last name: Huseyin K Bektasoglu, MD
phone: +902124531700
email: hkbektasoglu@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Turkey
responsible party type: Sponsor
mesh term: Obesity, Morbid
mesh term: Weight Loss
sharing ipd: Undecided