<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/NCT02984514</url>
  </required_header>
  <id_info>
    <org_study_id>Dnr 2015/191</org_study_id>
    <nct_id>NCT02984514</nct_id>
  </id_info>
  <brief_title>Brown Adipose Tissue in Type 1 Diabetes</brief_title>
  <official_title>Studies of Activity of Brown Adipose Tissue With Positron Emission Tomography Using the Tracer 18F-deoxy Glucose in Patients With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Per-Ola Carlsson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uppsala University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Brown adipose tissue has the capacity to consume large amounts of energy and has&#xD;
      insulin-independent glucose uptake. The investigators have recently observed an inverse&#xD;
      correlation between irisin levels and insulin needs of type 1 diabetes patients.&#xD;
      Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood&#xD;
      glucose levels.&#xD;
&#xD;
      In this study 12 patients with long-standing type 1 diabetes (&gt;10 years) and with variable&#xD;
      exogenous insulin needs will be investigated for amount of brown adipose tissue with positron&#xD;
      emission tomography using the tracer 18F-deoxy glucose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Activity of brown adipose tissue in correlation to exogenous insulin needs using the tracer 18F-deoxy glucose in positron emission tomography measurements</measure>
    <time_frame>Assessment performed after more than 10 years of diagnosed type 1 diabetes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucose uptake in muscle in correlation to exogenous insulin needs; assessment using the tracer 18F deoxy glucose in positron emission tomography measurements.</measure>
    <time_frame>Assessment performed after more than 10 years of diagnosed type 1 diabetes</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>Type 1 diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Positron emission tomography with tracer 18F-deoxy glucose</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Positron emission tomography with tracer 18F-deoxy glucose</intervention_name>
    <description>Assessment of activity of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose</description>
    <arm_group_label>Type 1 diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients (18 years of age or more)&#xD;
&#xD;
          2. Type 1 diabetes diagnose for more than 10 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ongoing pregnancy&#xD;
&#xD;
          2. Ongoing breast-feeding&#xD;
&#xD;
          3. BMI&lt;19&#xD;
&#xD;
          4. BMI &gt;30&#xD;
&#xD;
          5. P-creatinine &lt;110 µmol/l&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <zip>751 23</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>October 10, 2018</last_update_submitted>
  <last_update_submitted_qc>October 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Uppsala University Hospital</investigator_affiliation>
    <investigator_full_name>Per-Ola Carlsson</investigator_full_name>
    <investigator_title>Professor, Senior consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deoxyglucose</mesh_term>
  </intervention_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/NCT02984514
org study id: Dnr 2015/191
nct id: NCT02984514
lead sponsor: 
has dmc: No
Brown adipose tissue has the capacity to consume large amounts of energy and has
      insulin-independent glucose uptake. The investigators have recently observed an inverse
      correlation between irisin levels and insulin needs of type 1 diabetes patients.
      Transplantation of brown adipose tissue to insulin-deficient rats normalized their blood
      glucose levels.

      In this study 12 patients with long-standing type 1 diabetes (>10 years) and with variable
      exogenous insulin needs will be investigated for amount of brown adipose tissue with positron
      emission tomography using the tracer 18F-deoxy glucose.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Activity of brown adipose tissue in correlation to exogenous insulin needs using the tracer 18F-deoxy glucose in positron emission tomography measurements
time frame: Assessment performed after more than 10 years of diagnosed type 1 diabetes
measure: Glucose uptake in muscle in correlation to exogenous insulin needs; assessment using the tracer 18F deoxy glucose in positron emission tomography measurements.
time frame: Assessment performed after more than 10 years of diagnosed type 1 diabetes
arm group label: Type 1 diabetes
arm group type: Experimental
description: Positron emission tomography with tracer 18F-deoxy glucose
intervention type: Radiation
intervention name: Positron emission tomography with tracer 18F-deoxy glucose
description: Assessment of activity of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose
arm group label: Type 1 diabetes
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Uppsala University Hospital
investigator full name: Per-Ola Carlsson
investigator title: Professor, Senior consultant
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Deoxyglucose