<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/NCT01708083</url>
  </required_header>
  <id_info>
    <org_study_id>2009/1629-31/3</org_study_id>
    <nct_id>NCT01708083</nct_id>
  </id_info>
  <brief_title>Polymorphids an mRNA Expression in Obese Genes</brief_title>
  <official_title>Polymorphids and mRNA Expression in Genes, Significant for Developing Obesity and Typ II Diabetes in Different Types/Localisations of Fat Tissue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing&#xD;
      laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).&#xD;
&#xD;
      Are there any difference in polymorphids and/or mRNA expression in genes significant for&#xD;
      developing obesity, between normal weight and obese individuals, with or without diabetes typ&#xD;
      2 .&#xD;
&#xD;
      Are there any difference in polymorphids and/or mRNA expression in different types of fat&#xD;
      tissue&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in polymorphids and/or mRNA expression in genes, significant for developing obesity and type 2 diabetes, between patients with normal weight and obesity</measure>
    <time_frame>approximatly 30 minutes after start of operation</time_frame>
    <description>fat biopsy taken from abdomen, omenta and thigh at surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in polymorphids and/or mRNA expression in different types of fat tissue in patients with normal weight or obesity with or without diabetes type 2</measure>
    <time_frame>approximatly 30 minutes after start of operation</time_frame>
    <description>fat biopsy; abdomen, omenta and thigh taken at surgery</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Polymorphism</condition>
  <condition>mRNA Expression</condition>
  <arm_group>
    <arm_group_label>Type 2 Diabetes and BMI&gt;35</arm_group_label>
    <description>Patients with type 2 diabetes and body mass index 35 or more.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI&gt;35</arm_group_label>
    <description>Patients undergoing surgery, gastric bypass or cholecystectomy, without diabetes type 2 and body mass index 35 or more</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI 18-27</arm_group_label>
    <description>Patients undergoing surgery, cholecystectomy or reflux, without type 2 diabetes and body mass index between 18-27</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      biopsys; Fat from oment, thigh and abdomen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Tree groups; group I: diabetes type II with BMI&gt;35 Group II: no diabetes BMI&gt;35 Group III:&#xD;
        no diabetes BMI 18-27&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 years or older&#xD;
&#xD;
          -  laparoscopic surgery (Gastric by-pass, cholecystectomy, antireflux surgery)&#xD;
&#xD;
          -  Normal weight without type 2 diabetes BMI 18-25&#xD;
&#xD;
          -  Obese without type 2 diabetes BMI&gt;35&#xD;
&#xD;
          -  Obese with type 2 diabetes BMI&gt;35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years&#xD;
&#xD;
          -  open surgery&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  BMI &gt;27-&lt;35&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders Thorell, Ass. prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ersta hospital</name>
      <address>
        <city>Stockholm</city>
        <state>Stockholm County Council</state>
        <zip>116 91</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska Institutet, CMM</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>August 21, 2013</last_update_submitted>
  <last_update_submitted_qc>August 21, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Anders Thorell</investigator_full_name>
    <investigator_title>Associated professor, MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT01708083
org study id: 2009/1629-31/3
nct id: NCT01708083
lead sponsor: 
has dmc: No
Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing
      laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).

      Are there any difference in polymorphids and/or mRNA expression in genes significant for
      developing obesity, between normal weight and obese individuals, with or without diabetes typ
      2 .

      Are there any difference in polymorphids and/or mRNA expression in different types of fat
      tissue
observational model: Cohort
time perspective: Prospective
measure: Differences in polymorphids and/or mRNA expression in genes, significant for developing obesity and type 2 diabetes, between patients with normal weight and obesity
time frame: approximatly 30 minutes after start of operation
description: fat biopsy taken from abdomen, omenta and thigh at surgery
measure: Difference in polymorphids and/or mRNA expression in different types of fat tissue in patients with normal weight or obesity with or without diabetes type 2
time frame: approximatly 30 minutes after start of operation
description: fat biopsy; abdomen, omenta and thigh taken at surgery
arm group label: Type 2 Diabetes and BMI>35
description: Patients with type 2 diabetes and body mass index 35 or more.
arm group label: BMI>35
description: Patients undergoing surgery, gastric bypass or cholecystectomy, without diabetes type 2 and body mass index 35 or more
arm group label: BMI 18-27
description: Patients undergoing surgery, cholecystectomy or reflux, without type 2 diabetes and body mass index between 18-27
biopsys; Fat from oment, thigh and abdomen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anders Thorell, Ass. prof.
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Anders Thorell
investigator title: Associated professor, MD