<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/NCT02967354</url>
  </required_header>
  <id_info>
    <org_study_id>Dnr 2012/302</org_study_id>
    <nct_id>NCT02967354</nct_id>
  </id_info>
  <brief_title>[11C]5-Hydroxy-tryptophan PET for Assessment of Islet Mass in Type 2 Diabetes</brief_title>
  <official_title>[11C]5-Hydroxy-tryptophan Positron Emission Tomography for Assessment of Islet Mass During Progression of Type 2 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>
      Cross-sectional study to investigate subjects at different stages of type 2 diabetes&#xD;
      development with expected stratification of pancreatic islet mass. Non-diabetic individuals&#xD;
      were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and&#xD;
      retention in the pancreas as a surrogate marker for the endogenous islet mass.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>[11C]5-hydroxy-tryptophan Uptake in the Pancreas</measure>
    <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
    <description>Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pancreatic Perfusion</measure>
    <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
    <description>Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pancreatic Volume</measure>
    <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pancreatic Fat Content</measure>
    <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic Fat Content</measure>
    <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese with oral antidiabetic drugs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese, treated with oral antidiabetic drugs + insulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal weight, treated with oral antidiabetic drugs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal weight, treated with oral antidiabetic drugs + insulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan</intervention_name>
    <description>Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Normal weight, treated with oral antidiabetic drugs</arm_group_label>
    <arm_group_label>Normal weight, treated with oral antidiabetic drugs + insulin</arm_group_label>
    <arm_group_label>Obese with oral antidiabetic drugs</arm_group_label>
    <arm_group_label>Obese, treated with oral antidiabetic drugs + insulin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes fulfilling criteria for the four different study groups, or healthy&#xD;
             volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing pregnancy&#xD;
&#xD;
          -  Renal failure (GFR&lt;60 ml/min)&#xD;
&#xD;
          -  Magnetic metal parts in the body&#xD;
&#xD;
          -  Ongoing treatment with selective serotonin receptor inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>October 26, 2017</results_first_submitted>
  <results_first_submitted_qc>October 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 29, 2017</results_first_posted>
  <last_update_submitted>January 4, 2018</last_update_submitted>
  <last_update_submitted_qc>January 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 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 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tryptophan</mesh_term>
    <mesh_term>5-Hydroxytryptophan</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Healthy Control</title>
          <description>Healthy control&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="P2">
          <title>Obese With Oral Antidiabetic Drugs</title>
          <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="P3">
          <title>Obese, Treated With Oral Antidiabetic Drugs + Insulin</title>
          <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs + insulin&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="P4">
          <title>Normal Weight, Treated With Oral Antidiabetic Drugs</title>
          <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="P5">
          <title>Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin</title>
          <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy Control</title>
          <description>Healthy control&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="B2">
          <title>Obese With Oral Antidiabetic Drugs</title>
          <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="B3">
          <title>Obese, Treated With Oral Antidiabetic Drugs + Insulin</title>
          <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs + insulin&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="B4">
          <title>Normal Weight, Treated With Oral Antidiabetic Drugs</title>
          <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="B5">
          <title>Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin</title>
          <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="7"/>
            <count group_id="B5" value="8"/>
            <count group_id="B6" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="9"/>
                    <count group_id="B4" value="7"/>
                    <count group_id="B5" value="8"/>
                    <count group_id="B6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.3" spread="6.2"/>
                    <measurement group_id="B2" value="56.7" spread="10.1"/>
                    <measurement group_id="B3" value="61.8" spread="7.2"/>
                    <measurement group_id="B4" value="60.3" spread="10.8"/>
                    <measurement group_id="B5" value="66.3" spread="5.4"/>
                    <measurement group_id="B6" value="61.8" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="9"/>
                    <count group_id="B4" value="7"/>
                    <count group_id="B5" value="8"/>
                    <count group_id="B6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Sweden</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="9"/>
                    <count group_id="B4" value="7"/>
                    <count group_id="B5" value="8"/>
                    <count group_id="B6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="7"/>
                    <count group_id="B3" value="9"/>
                    <count group_id="B4" value="7"/>
                    <count group_id="B5" value="8"/>
                    <count group_id="B6" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.1" spread="3.4"/>
                    <measurement group_id="B2" value="33.3" spread="2.6"/>
                    <measurement group_id="B3" value="33.2" spread="3.6"/>
                    <measurement group_id="B4" value="25.1" spread="2.4"/>
                    <measurement group_id="B5" value="25.8" spread="1.4"/>
                    <measurement group_id="B6" value="29.2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>[11C]5-hydroxy-tryptophan Uptake in the Pancreas</title>
        <description>Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release</description>
        <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
        <population>Two healthy controls and two individuals in the group &quot;Normal weight, treated with oral antidiabetic drugs + insulin were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>Healthy control&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
          </group>
          <group group_id="O2">
            <title>Obese With Oral Antidiabetic Drugs</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
          </group>
          <group group_id="O3">
            <title>Obese, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs + insulin&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
          </group>
          <group group_id="O4">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
          </group>
          <group group_id="O5">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
          </group>
        </group_list>
        <measure>
          <title>[11C]5-hydroxy-tryptophan Uptake in the Pancreas</title>
          <description>Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release</description>
          <population>Two healthy controls and two individuals in the group &quot;Normal weight, treated with oral antidiabetic drugs + insulin were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality.</population>
          <units>% of injected dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="0.04"/>
                    <measurement group_id="O2" value="0.21" spread="0.10"/>
                    <measurement group_id="O3" value="0.20" spread="0.07"/>
                    <measurement group_id="O4" value="0.23" spread="0.11"/>
                    <measurement group_id="O5" value="0.15" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5875</p_value>
            <p_value_desc>Treshold for significance P&lt;0.05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pancreatic Perfusion</title>
        <description>Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release</description>
        <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
        <population>Some individuals in the study population were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>Healthy control.</description>
          </group>
          <group group_id="O2">
            <title>Obese With Oral Antidiabetic Drugs</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs</description>
          </group>
          <group group_id="O3">
            <title>Obese, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
          </group>
          <group group_id="O4">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs</description>
          </group>
          <group group_id="O5">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Pancreatic Perfusion</title>
          <description>Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release</description>
          <population>Some individuals in the study population were not included in the analysis because of not being able to participate in the PET scan, pancreatic anatomical abnormality or insufficient image quality.</population>
          <units>ml/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.37" spread="18.17"/>
                    <measurement group_id="O2" value="134.90" spread="47.84"/>
                    <measurement group_id="O3" value="107.72" spread="32.91"/>
                    <measurement group_id="O4" value="72.20" spread="18.88"/>
                    <measurement group_id="O5" value="59.82" spread="51.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0065</p_value>
            <p_value_desc>Treshold for significance P&lt;0.05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pancreatic Volume</title>
        <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
        <population>Some participants were not included in the analysis because of not being able to participate in the imaging, pancreatic anatomical abnormality or insufficient image quality.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>Healthy control.</description>
          </group>
          <group group_id="O2">
            <title>Obese With Oral Antidiabetic Drugs</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs</description>
          </group>
          <group group_id="O3">
            <title>Obese, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
          </group>
          <group group_id="O4">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs</description>
          </group>
          <group group_id="O5">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Pancreatic Volume</title>
          <population>Some participants were not included in the analysis because of not being able to participate in the imaging, pancreatic anatomical abnormality or insufficient image quality.</population>
          <units>cm^3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.68" spread="8.90"/>
                    <measurement group_id="O2" value="88.54" spread="23.99"/>
                    <measurement group_id="O3" value="98.96" spread="23.85"/>
                    <measurement group_id="O4" value="64.1" spread="13.46"/>
                    <measurement group_id="O5" value="53.39" spread="41.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0072</p_value>
            <p_value_desc>Treshold for significance P&lt;0.05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pancreatic Fat Content</title>
        <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
        <population>Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan, pancreatic anatomical abnormality or insufficient image quality.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>Healthy control.</description>
          </group>
          <group group_id="O2">
            <title>Obese With Oral Antidiabetic Drugs</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs</description>
          </group>
          <group group_id="O3">
            <title>Obese, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
          </group>
          <group group_id="O4">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs</description>
          </group>
          <group group_id="O5">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Pancreatic Fat Content</title>
          <population>Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan, pancreatic anatomical abnormality or insufficient image quality.</population>
          <units>% of pancreatic volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.33" spread="7.62"/>
                    <measurement group_id="O2" value="11.54" spread="10.30"/>
                    <measurement group_id="O3" value="8.75" spread="2.97"/>
                    <measurement group_id="O4" value="9.58" spread="9.37"/>
                    <measurement group_id="O5" value="9.72" spread="7.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9472</p_value>
            <p_value_desc>Treshold for significance P&lt;0.05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hepatic Fat Content</title>
        <time_frame>Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release</time_frame>
        <population>Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan or insufficient image quality.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy Control</title>
            <description>Healthy control.</description>
          </group>
          <group group_id="O2">
            <title>Obese With Oral Antidiabetic Drugs</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs</description>
          </group>
          <group group_id="O3">
            <title>Obese, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
          </group>
          <group group_id="O4">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs</description>
          </group>
          <group group_id="O5">
            <title>Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin</title>
            <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin</description>
          </group>
        </group_list>
        <measure>
          <title>Hepatic Fat Content</title>
          <population>Some of the study participants were not included in the analysis because of not being able to participate in the MRI scan or insufficient image quality.</population>
          <units>% of liver volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.30" spread="3.15"/>
                    <measurement group_id="O2" value="14.40" spread="7.18"/>
                    <measurement group_id="O3" value="13.42" spread="7.14"/>
                    <measurement group_id="O4" value="5.50" spread="2.98"/>
                    <measurement group_id="O5" value="9.01" spread="4.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0048</p_value>
            <p_value_desc>Treshold for significance P&lt;0.05</p_value_desc>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Healthy Control</title>
          <description>Healthy control&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="E2">
          <title>Obese With Oral Antidiabetic Drugs</title>
          <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="E3">
          <title>Obese, Treated With Oral Antidiabetic Drugs + Insulin</title>
          <description>BMI&gt;30, Type 2 diabetes treated with oral antidiabetic drugs + insulin&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="E4">
          <title>Normal Weight, Treated With Oral Antidiabetic Drugs</title>
          <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
        <group group_id="E5">
          <title>Normal Weight, Treated With Oral Antidiabetic Drugs + Insulin</title>
          <description>BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin&#xD;
Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Per-Ola Carlsson</name_or_title>
      <organization>Uppsala University Hospital</organization>
      <phone>+46184714425</phone>
      <email>per-ola.carlsson@mcb.uu.se</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02967354
org study id: Dnr 2012/302
nct id: NCT02967354
lead sponsor: 
has dmc: No
Cross-sectional study to investigate subjects at different stages of type 2 diabetes
      development with expected stratification of pancreatic islet mass. Non-diabetic individuals
      were assigned as control. The primary outcome was the [11C]5-hydroxy-tryptophan uptake and
      retention in the pancreas as a surrogate marker for the endogenous islet mass.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: [11C]5-hydroxy-tryptophan Uptake in the Pancreas
time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
description: Uptake of tracer with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
measure: Pancreatic Perfusion
time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
description: Uptake of radioactive water with correlation to functional measurement with glucose-potentiated arginine stimulation of insulin release
measure: Pancreatic Volume
time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
measure: Pancreatic Fat Content
time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
measure: Hepatic Fat Content
time frame: Within two weeks after functional measurement with glucose potentiated arginine stimulation of insulin release
arm group label: Healthy control
arm group type: Experimental
description: Healthy control
arm group label: Obese with oral antidiabetic drugs
arm group type: Experimental
description: BMI>30, Type 2 diabetes treated with oral antidiabetic drugs
arm group label: Obese, treated with oral antidiabetic drugs + insulin
arm group type: Experimental
description: BMI>30, Type 2 diabetes treated with oral antidiabetic drugs + insulin
arm group label: Normal weight, treated with oral antidiabetic drugs
arm group type: Experimental
description: BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs
arm group label: Normal weight, treated with oral antidiabetic drugs + insulin
arm group type: Experimental
description: BMI 20-26. Type 2 diabetes treated with oral antidiabetic drugs + insulin
intervention type: Radiation
intervention name: Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan
description: Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan
arm group label: Healthy control
arm group label: Normal weight, treated with oral antidiabetic drugs
arm group label: Normal weight, treated with oral antidiabetic drugs + insulin
arm group label: Obese with oral antidiabetic drugs
arm group label: Obese, treated with oral antidiabetic drugs + insulin
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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 2
mesh term: Tryptophan
mesh term: 5-Hydroxytryptophan
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 