<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/NCT03244839</url>
  </required_header>
  <id_info>
    <org_study_id>2016007</org_study_id>
    <nct_id>NCT03244839</nct_id>
  </id_info>
  <brief_title>Prevalence of Major Nutrients Deficiency in Diabetic Patient Before and After Bariatric Surgery</brief_title>
  <official_title>Prevalence of Major Nutrients Deficiency in Diabetic Patient Before and After Bariatric Surgery</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>
      The increasing demand of bariatric surgery requires ongoing improvement of the preoperative&#xD;
      and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery&#xD;
      mainly focuses on weight loss, improvement of co-morbidities and quality of life.&#xD;
      Post-operative nutritional deficiencies are a complication of bariatric surgery, in&#xD;
      particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and&#xD;
      D are frequently reported and may occur despite supplementation. Morbid obesity itself is&#xD;
      associated with nutritional deficiencies as well, which become worsening after bariatric&#xD;
      surgery. The occurrence of nutritional deficiencies has been reported in the literature but&#xD;
      not in Taiwan. The goal of the current study is to determine the prevalence and incidence of&#xD;
      nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving&#xD;
      standard supplementation in Taiwan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The increasing demand of bariatric surgery requires ongoing improvement of the preoperative&#xD;
      and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery&#xD;
      mainly focuses on weight loss, improvement of co-morbidities and quality of life.&#xD;
      Post-operative nutritional deficiencies are a complication of bariatric surgery, in&#xD;
      particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and&#xD;
      D are frequently reported and may occur despite supplementation. Morbid obesity itself is&#xD;
      associated with nutritional deficiencies as well, which become worsening after bariatric&#xD;
      surgery. The occurrence of nutritional deficiencies has been reported in the literature but&#xD;
      not in Taiwan. The goal of the current study is to determine the prevalence and incidence of&#xD;
      nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving&#xD;
      standard supplementation in Taiwan&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Prevalence of major nutrients deficiency in diabetic patient before and after bariatric surgery</measure>
    <time_frame>3 years</time_frame>
    <description>Prevalence of major nutrients deficiency in diabetic patient before and after bariatric surgery</description>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Diabetic Patient Before and After Bariatric Surgery</condition>
  <condition>Nutrition Deficiency(VitB1 VitB12.Ca.Fe)</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>bariatric surgery</intervention_name>
    <description>bariatric surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Diabetic patients underwent bariatric surgery in MSGH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 20~65&#xD;
&#xD;
          -  Diabetic patients underwent bariatric surgery in MSGH&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Cancer on treatment&#xD;
&#xD;
          -  Uncontrolled psychiatric disease&#xD;
&#xD;
          -  Drug or alcohol abuser&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Min sheng general hospital</name>
      <address>
        <city>Taoyuan city</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Shiffman ML, Sugerman HJ, Kellum JM, Moore EW. Changes in gallbladder bile composition following gallstone formation and weight reduction. Gastroenterology. 1992 Jul;103(1):214-21. doi: 10.1016/0016-5085(92)91115-k.</citation>
    <PMID>1612328</PMID>
  </results_reference>
  <results_reference>
    <citation>Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5.</citation>
    <PMID>1858735</PMID>
  </results_reference>
  <results_reference>
    <citation>Williams C, Gowan R, Perey BJ. A Double-Blind Placebo-controlled Trial of Ursodeoxycholic Acid in the Prevention of Gallstones during Weight Loss after Vertical Banded Gastroplasty. Obes Surg. 1993 Aug;3(3):257-259. doi: 10.1381/096089293765559278.</citation>
    <PMID>10757929</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03244839
org study id: 2016007
nct id: NCT03244839
lead sponsor: 
has dmc: Yes
The increasing demand of bariatric surgery requires ongoing improvement of the preoperative
      and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery
      mainly focuses on weight loss, improvement of co-morbidities and quality of life.
      Post-operative nutritional deficiencies are a complication of bariatric surgery, in
      particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and
      D are frequently reported and may occur despite supplementation. Morbid obesity itself is
      associated with nutritional deficiencies as well, which become worsening after bariatric
      surgery. The occurrence of nutritional deficiencies has been reported in the literature but
      not in Taiwan. The goal of the current study is to determine the prevalence and incidence of
      nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving
      standard supplementation in Taiwan.
The increasing demand of bariatric surgery requires ongoing improvement of the preoperative
      and post-operative care of morbidly obese patients. Outcome reporting in bariatric surgery
      mainly focuses on weight loss, improvement of co-morbidities and quality of life.
      Post-operative nutritional deficiencies are a complication of bariatric surgery, in
      particular after malabsorptive procedures. Deficiencies of protein, iron and vitamins B12 and
      D are frequently reported and may occur despite supplementation. Morbid obesity itself is
      associated with nutritional deficiencies as well, which become worsening after bariatric
      surgery. The occurrence of nutritional deficiencies has been reported in the literature but
      not in Taiwan. The goal of the current study is to determine the prevalence and incidence of
      nutritional deficiencies in diabetic patients underwent bariatric surgery and receiving
      standard supplementation in Taiwan
observational model: Case-Only
time perspective: Prospective
measure: Prevalence of major nutrients deficiency in diabetic patient before and after bariatric surgery
time frame: 3 years
description: Prevalence of major nutrients deficiency in diabetic patient before and after bariatric surgery
intervention type: Procedure
intervention name: bariatric surgery
description: bariatric surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Taiwan
citation: Shiffman ML, Sugerman HJ, Kellum JM, Moore EW. Changes in gallbladder bile composition following gallstone formation and weight reduction. Gastroenterology. 1992 Jul;103(1):214-21. doi: 10.1016/0016-5085(92)91115-k.
PMID: 1612328
citation: Shiffman ML, Sugerman HJ, Kellum JM, Brewer WH, Moore EW. Gallstone formation after rapid weight loss: a prospective study in patients undergoing gastric bypass surgery for treatment of morbid obesity. Am J Gastroenterol. 1991 Aug;86(8):1000-5.
PMID: 1858735
citation: Williams C, Gowan R, Perey BJ. A Double-Blind Placebo-controlled Trial of Ursodeoxycholic Acid in the Prevention of Gallstones during Weight Loss after Vertical Banded Gastroplasty. Obes Surg. 1993 Aug;3(3):257-259. doi: 10.1381/096089293765559278.
PMID: 10757929
responsible party type: Sponsor
sharing ipd: No