<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/NCT02193529</url>
  </required_header>
  <id_info>
    <org_study_id>DIA-LSG</org_study_id>
    <secondary_id>DIA5y</secondary_id>
    <nct_id>NCT02193529</nct_id>
  </id_info>
  <brief_title>Dietary Intake After Laparoscopic Sleeve Gastrectomy -a 5 Year Study</brief_title>
  <official_title>Weight Loss and Metabolic Surgery Center Min-Sheng General Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Min-Sheng General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Min-Sheng General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Weight reducing surgery is the only effective therapy for morbid obese patients.&#xD;
&#xD;
      Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There&#xD;
      is poor knowledge about the nutritional status inpatients after LSG. The aim of our study was&#xD;
      to investigate the relationship between dietary intake and weight loss after LSG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Weight reducing surgery is the only effective therapy for morbid obese patients. Restrictive&#xD;
      type surgery is safer than mal-absorptive type surgery. Laparoscopic sleeve gastrectomy is an&#xD;
      effective surgery. In laparoscopic sleeve gastrectomy (LSG), about 90% of the stomach is&#xD;
      surgically removed by vertical resection of the great curvature side, including the fundus.&#xD;
      The simplicity of surgical procedures, the low occurrence of complications, and the&#xD;
      efficiency of reducing excess weight have made LSG as a popular choice for bariatric surgery.&#xD;
      After LSG, the amount of food eaten is drastically reduced, leading to nutritional&#xD;
      deficiencies potentially. There is poor knowledge about the nutritional status inpatients&#xD;
      after LSG. Some literatures suggest that LSG results in less nutritional deficiencies than&#xD;
      Roux-en-Y gastric bypass. The aim of our study was to investigate the relationship between&#xD;
      dietary intake and weight loss after LSG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary intake after laparoscopic sleeve gastrectomy 5 years</measure>
    <time_frame>up to 18 months</time_frame>
    <description>The aim of this study was to investigate the relationship between dietary intake and weight loss effect after sleeve gastrectomy.The calculation of the majority of the nutrients is based on Australian nutrient composition data. The item include: energy ( kcal/day), protein, fat, carbohydrate, vitamin and minerals.</description>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Morbid Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        morbid obesity patients received laparoscopic sleeve gastrectomy for more then 5 years. BMI&#xD;
        above 40 kg/m2 when operation. Age 18-65 years old.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  morbid obesity patients received laparoscopic sleeve gastrectomy for more then 5&#xD;
             years.&#xD;
&#xD;
        BMI above 40 kg/m2 when operation. Age 18-65 years old. No major psychosis or binge eating&#xD;
        disorder. No endocrine disease. failed to lose weight with medical therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current hepatitis, under steroid treatment,cancer, thyroid disease,alcoholism.&#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>Ju J Chou, university</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nutrition and Health Sciences,Taipei Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ju J Chou, university</last_name>
    <phone>886933164297</phone>
    <email>n002434@e-ms.com.tw</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jung C Chen, university</last_name>
    <phone>886933164297</phone>
    <email>jackykenzero@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Weight Loss and Metabolic Surgery Center Min-Sheng General Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>330</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ju J Chou, university</last_name>
      <phone>886933164297</phone>
      <email>n002434@e-ms.com.tw</email>
    </contact>
    <contact_backup>
      <last_name>Jung C Chen, university</last_name>
      <phone>886933164297</phone>
      <email>jackykenzero@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Ju J Chou, university</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Min-Sheng General Hospital</investigator_affiliation>
    <investigator_full_name>WEI-CHENG YAO</investigator_full_name>
    <investigator_title>Institutional Review Board</investigator_title>
  </responsible_party>
  <keyword>sleeve gastrectomy, dietary intake, morbid obesity.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <!-- 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/NCT02193529
org study id: DIA-LSG
secondary id: DIA5y
nct id: NCT02193529
lead sponsor: 
has dmc: Yes
Weight reducing surgery is the only effective therapy for morbid obese patients.

      Sleeve gastrectomy is a popular choice for bariatric surgery because of less sequela. There
      is poor knowledge about the nutritional status inpatients after LSG. The aim of our study was
      to investigate the relationship between dietary intake and weight loss after LSG.
Weight reducing surgery is the only effective therapy for morbid obese patients. Restrictive
      type surgery is safer than mal-absorptive type surgery. Laparoscopic sleeve gastrectomy is an
      effective surgery. In laparoscopic sleeve gastrectomy (LSG), about 90% of the stomach is
      surgically removed by vertical resection of the great curvature side, including the fundus.
      The simplicity of surgical procedures, the low occurrence of complications, and the
      efficiency of reducing excess weight have made LSG as a popular choice for bariatric surgery.
      After LSG, the amount of food eaten is drastically reduced, leading to nutritional
      deficiencies potentially. There is poor knowledge about the nutritional status inpatients
      after LSG. Some literatures suggest that LSG results in less nutritional deficiencies than
      Roux-en-Y gastric bypass. The aim of our study was to investigate the relationship between
      dietary intake and weight loss after LSG.
observational model: Case-Only
time perspective: Retrospective
measure: Dietary intake after laparoscopic sleeve gastrectomy 5 years
time frame: up to 18 months
description: The aim of this study was to investigate the relationship between dietary intake and weight loss effect after sleeve gastrectomy.The calculation of the majority of the nutrients is based on Australian nutrient composition data. The item include: energy ( kcal/day), protein, fat, carbohydrate, vitamin and minerals.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ju J Chou, university
role: Principal Investigator
affiliation: School of Nutrition and Health Sciences,Taipei Medical University
last name: Ju J Chou, university
phone: 886933164297
email: n002434@e-ms.com.tw
last name: Jung C Chen, university
phone: 886933164297
email: jackykenzero@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Min-Sheng General Hospital
investigator full name: WEI-CHENG YAO
investigator title: Institutional Review Board
mesh term: Obesity, Morbid