<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/NCT01708096</url>
  </required_header>
  <id_info>
    <org_study_id>2009/931-31/2</org_study_id>
    <nct_id>NCT01708096</nct_id>
  </id_info>
  <brief_title>Mechanisms Behind Antidiabetic Effects by Gastric By-pass</brief_title>
  <official_title>Mechanisms Behind Antidiabetic Effects by Gastric By-pass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uppsala 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>
      The aim of the study is to develop new strategies in treatment of continuous increasing&#xD;
      number of patients with type 2 diabetes by understanding how bariatric surgery cures or&#xD;
      improves this condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insulin sensitivity</measure>
    <time_frame>12-18 month after gastric bypass</time_frame>
    <description>Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight reduction</measure>
    <time_frame>12-18 month after gastric bypass</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Insulin signaling and glucose transport in skeletal muscle</measure>
    <time_frame>12-18 month after gastric by-pass</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Diabetes Mellitus Typ 2 and Obesity</condition>
  <arm_group>
    <arm_group_label>Modifast</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>treated with VLD Modifast 1000 kcal/day in 2 weeks before gastric by-pass,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal diet 2 weeks before gastric by-pass surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Modifast</intervention_name>
    <description>2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day</description>
    <arm_group_label>Modifast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Normal diet</intervention_name>
    <description>normal diet 2 weeks before gastric by-pass</description>
    <arm_group_label>Normal diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes typ 2&#xD;
&#xD;
          -  18-70 years&#xD;
&#xD;
          -  BMI &gt; 35 kg/m2&#xD;
&#xD;
          -  Treated with oral antidiabetic agents and/or insulin&#xD;
&#xD;
          -  laparoscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pharmacological treatment (other then above) witch could affect glucose metabolism&#xD;
&#xD;
          -  open surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anders Thorell, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska Institutet</name>
      <address>
        <city>Stockholm</city>
        <state>Stockholm County Council</state>
        <zip>116 91</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2014</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>March 11, 2014</last_update_submitted>
  <last_update_submitted_qc>March 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 12, 2014</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>Assoc. 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/NCT01708096
org study id: 2009/931-31/2
nct id: NCT01708096
lead sponsor: 
collaborator: 
has dmc: No
The aim of the study is to develop new strategies in treatment of continuous increasing
      number of patients with type 2 diabetes by understanding how bariatric surgery cures or
      improves this condition.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Insulin sensitivity
time frame: 12-18 month after gastric bypass
description: Insulin sensitivity measured by hyperinsulinemic normoglycemic clamp technique
measure: Weight reduction
time frame: 12-18 month after gastric bypass
measure: Insulin signaling and glucose transport in skeletal muscle
time frame: 12-18 month after gastric by-pass
arm group label: Modifast
arm group type: Active Comparator
description: treated with VLD Modifast 1000 kcal/day in 2 weeks before gastric by-pass,
arm group label: Normal diet
arm group type: Placebo Comparator
description: normal diet 2 weeks before gastric by-pass surgery
intervention type: Dietary Supplement
intervention name: Modifast
description: 2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day
arm group label: Modifast
intervention type: Dietary Supplement
intervention name: Normal diet
description: normal diet 2 weeks before gastric by-pass
arm group label: Normal diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Anders Thorell, Assoc 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: Assoc. Professor