<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/NCT03285750</url>
  </required_header>
  <id_info>
    <org_study_id>GPR120 study</org_study_id>
    <nct_id>NCT03285750</nct_id>
  </id_info>
  <brief_title>Expression of G-protein Coupled Receptor 120 Receptor in Adipose Tissue of German Diabetes Center Cohort Subjects</brief_title>
  <acronym>GPR120</acronym>
  <official_title>Expression of GPR120 Receptor in Adipose Tissue of Type 2 Diabetic Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Diabetes Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>German Diabetes Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      G-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous&#xD;
      ligands have been identified as long-chain fatty acids. Recently, it has been shown that&#xD;
      GPR120 expression in human adipose tissue is higher in obese than in lean individuals.&#xD;
      Interestingly, a GPR120 deficient mouse model presents an unfavorable phenotype when fed a&#xD;
      high-fat diet with obesity, glucose intolerance and fatty liver, characteristics also found&#xD;
      in type 2 diabetes (T2D).&#xD;
&#xD;
      Moreover, in obese subjects, a single nucleotide polymorphism (R270H) has been identified&#xD;
      that inhibits GPR120 signaling activity.&#xD;
&#xD;
      The investigators now want to investigate if GPR120 expression in adipose tissue may be&#xD;
      altered in patients with T2D compared to non-diabetic subjects and might contribute to&#xD;
      diabetes-associated metabolic changes. Additionally, the investigators want to assess the&#xD;
      frequency of the R270H mutant in T2D.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>GPR120 expression in adipose tissue</measure>
    <time_frame>Expression measured at baseline (day 1)</time_frame>
    <description>GPR expression is measured in adipose tissue of recently diagnosed type 2 diabetic patients and age- and BMI-matched normoglycemic controls</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Diabetic group</arm_group_label>
    <description>Patients with recently diagnosed type 2 diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Age- and BMI-matched normoglycemic subjects</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      SNP Genotyping of GPR120&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with recently diagnosed type 2 diabetes (up to one year from diagnosis) and age-&#xD;
        and weight-matched normoglycemic controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes mellitus / normoglycemia&#xD;
&#xD;
          -  BMI &lt; 27,5 or &gt; 30 kg/m2&#xD;
&#xD;
          -  Age 20 - 69 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe chronic diseases&#xD;
&#xD;
          -  anemia&#xD;
&#xD;
          -  medication altering fatty acid metabolism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Roden, Prof., MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>German Diabetes Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>German Diabetes Center</name>
      <address>
        <city>Duesseldorf</city>
        <state>Nordrhein-Westfalen</state>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 13, 2013</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GPR120</keyword>
  <keyword>Adipose tissue</keyword>
  <keyword>Type 2 diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_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/NCT03285750
org study id: GPR120 study
nct id: NCT03285750
lead sponsor: 
has dmc: No
G-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous
      ligands have been identified as long-chain fatty acids. Recently, it has been shown that
      GPR120 expression in human adipose tissue is higher in obese than in lean individuals.
      Interestingly, a GPR120 deficient mouse model presents an unfavorable phenotype when fed a
      high-fat diet with obesity, glucose intolerance and fatty liver, characteristics also found
      in type 2 diabetes (T2D).

      Moreover, in obese subjects, a single nucleotide polymorphism (R270H) has been identified
      that inhibits GPR120 signaling activity.

      The investigators now want to investigate if GPR120 expression in adipose tissue may be
      altered in patients with T2D compared to non-diabetic subjects and might contribute to
      diabetes-associated metabolic changes. Additionally, the investigators want to assess the
      frequency of the R270H mutant in T2D.
observational model: Case-Control
time perspective: Cross-Sectional
measure: GPR120 expression in adipose tissue
time frame: Expression measured at baseline (day 1)
description: GPR expression is measured in adipose tissue of recently diagnosed type 2 diabetic patients and age- and BMI-matched normoglycemic controls
arm group label: Diabetic group
description: Patients with recently diagnosed type 2 diabetes
arm group label: Controls
description: Age- and BMI-matched normoglycemic subjects
SNP Genotyping of GPR120
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Roden, Prof., MD
role: Principal Investigator
affiliation: German Diabetes Center
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2