<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/NCT01727245</url>
  </required_header>
  <id_info>
    <org_study_id>2011/1002-31/1</org_study_id>
    <nct_id>NCT01727245</nct_id>
  </id_info>
  <brief_title>NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity</brief_title>
  <official_title>The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danderyd Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ersta Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We want to asses the role of adipose tissue for metabolic complications to obesity before and&#xD;
      after weight loss (surgery).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2011</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity, adipose tissue function and gene function</measure>
    <time_frame>two years after surgery</time_frame>
    <description>Performed with hyperinsulinemic euglycemic clamp before and two years after surgery. Subcutaneous and visceral fat biopsy at the time of surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>two years after surgery</time_frame>
    <description>DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular function</measure>
    <time_frame>two years after surgery</time_frame>
    <description>Non invasive ultrasound of vascular stiffness, before and two years after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Obesity</condition>
  <condition>Non-obese Controls</condition>
  <arm_group>
    <arm_group_label>Obese</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Obese patients undergoing gastric by-pass surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cholecystectomy and anti-reflux surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Obese</intervention_name>
    <description>gastric bypass</description>
    <arm_group_label>Obese</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Cholecystectomy and anti-reflux surgery</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria obese:&#xD;
&#xD;
          -  Bariatric surgery with laparoscopic gastric by-pass&#xD;
&#xD;
        Exclusion Criteria obese:&#xD;
&#xD;
          -  diabetes mellitus typ 2 with insulin treatment and/or glitazones&#xD;
&#xD;
          -  oral or parenteral steroid treatment&#xD;
&#xD;
          -  complicated psychiatric disease&#xD;
&#xD;
          -  Warfarin use&#xD;
&#xD;
        Inclusion Criteria non-obese controls:&#xD;
&#xD;
          -  BMI under 30&#xD;
&#xD;
        Exclusion Criteria non-obese controls:&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  oral or parenteral steroids treatment&#xD;
&#xD;
          -  complicated psychiatric disease&#xD;
&#xD;
          -  Warfarins use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erik Näslund, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ersta Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>116 91</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danderyds Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>182 88</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>February 27, 2020</last_update_submitted>
  <last_update_submitted_qc>February 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Erik Näslund</investigator_full_name>
    <investigator_title>Professor</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/NCT01727245
org study id: 2011/1002-31/1
nct id: NCT01727245
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
We want to asses the role of adipose tissue for metabolic complications to obesity before and
      after weight loss (surgery).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Insulin sensitivity, adipose tissue function and gene function
time frame: two years after surgery
description: Performed with hyperinsulinemic euglycemic clamp before and two years after surgery. Subcutaneous and visceral fat biopsy at the time of surgery.
measure: Body composition
time frame: two years after surgery
description: DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery
measure: Vascular function
time frame: two years after surgery
description: Non invasive ultrasound of vascular stiffness, before and two years after surgery
arm group label: Obese
arm group type: Other
description: Obese patients undergoing gastric by-pass surgery
arm group label: Control group
arm group type: Other
description: Cholecystectomy and anti-reflux surgery
intervention type: Other
intervention name: Obese
description: gastric bypass
arm group label: Obese
intervention type: Other
intervention name: Control group
description: Cholecystectomy and anti-reflux surgery
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Erik Näslund, Prof.
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Erik Näslund
investigator title: Professor