<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/NCT03823859</url>
  </required_header>
  <id_info>
    <org_study_id>EKNZ 2018-01961</org_study_id>
    <nct_id>NCT03823859</nct_id>
  </id_info>
  <brief_title>Metabolomics of Thyroid Hormones</brief_title>
  <acronym>MATcH</acronym>
  <official_title>Metabolomics of Thyroid Hormones</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ETH Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to develop a metabolome signature of thyroid hormone status. The&#xD;
      metabolome signature could be useful in diagnosis and treatment of thyroid dysfunction&#xD;
      diseases, especially in cases where TSH cannot be reliably used.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Hypothyroidism is a frequent endocrine disorder, where the thyroid gland does not&#xD;
      produce sufficient amounts of thyroid hormones. The substitution therapy is guided by&#xD;
      measurement of the pituitary gland hormone thyrotropin (TSH). Patients with central&#xD;
      hypothyroidism in whom pituitary insufficiency leads to hypothyroidism, TSH cannot be used to&#xD;
      guide therapy. So far there are no reliable methods for therapy control in patients with&#xD;
      central hypothyroidism.&#xD;
&#xD;
      The measurement of small endogenous metabolites might give investigators a metabolomics&#xD;
      profile. This could help to discriminate between euthyroid, hypothyroid and hyperthyroid&#xD;
      state and therefore could be used for diagnosis and therapy control of thyroid dysfunction&#xD;
      diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 28, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Metabolome signature of thyroid Hormone Status (MSTH)</measure>
    <time_frame>baseline/single visit</time_frame>
    <description>The MSTH will be tested against the current standard of diagnosis which is serum TSH level by multiple linear regression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resting energy expenditure (REE)</measure>
    <time_frame>baseline/single visit</time_frame>
    <description>Comparison of REE of healthy volunteers and Patients with thyroid dysfunction, measured by indirect calorimetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition concerning muscle mass</measure>
    <time_frame>baseline/single visit</time_frame>
    <description>Comparison of muscle mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition concerning fat mass</measure>
    <time_frame>baseline/single visit</time_frame>
    <description>Comparison of fat mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">332</enrollment>
  <condition>Central Hypothyroidism</condition>
  <condition>Hypothyroidism</condition>
  <condition>Hyperthyroidism</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)&#xD;
Indirect calorimetry&#xD;
Dual energy X-ray Absorptiometry (DXA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with thyroid dysfunction</arm_group_label>
    <description>Patients with Primary hypothyroidism newly diagnosed, Primary hypothyroidism substituted, hyperthyroidism, secondary hypothyroidism&#xD;
Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)&#xD;
Indirect calorimetry&#xD;
Dual energy X-ray Absorptiometry (DXA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Indirect calorimetry</intervention_name>
    <description>Resting energy expenditure</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with thyroid dysfunction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dual energy X-ray Absorptiometry (DXA)</intervention_name>
    <description>Body composition</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with thyroid dysfunction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Blood sampling</intervention_name>
    <description>fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Patients with thyroid dysfunction</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers will be recruited by means of advertisements (online or in the&#xD;
        newspaper).&#xD;
&#xD;
        Patients will be recruited from the endocrinology outpatient clinics of the Department of&#xD;
        Endocrinology, Diabetes and Metabolism, University Hospital Basel and patients referred&#xD;
        from practicing endocrinologists.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All participants:&#xD;
&#xD;
          -  Age 18 to 80 years&#xD;
&#xD;
          -  BMI 19 to 35 kg/m2&#xD;
&#xD;
          -  Informed consent as documented by signature&#xD;
&#xD;
        A) Patients with primary hyperthyroidism TSH &lt; 0.2 mIU/l and free thyroxine (fT4) &gt; 25 pM&#xD;
        or fT3 &gt; 8 pM&#xD;
&#xD;
        B) Patients with primary hypothyroidism, currently not sufficiently substituted TSH &gt; 8&#xD;
        milli-International unit (mIU)/l or fT4 &lt; 10 pM&#xD;
&#xD;
        C) Patients with diagnosis of primary hypothyroidism, sufficiently substituted Documented&#xD;
        diagnosis of primary hypothyroidism Substitution with L-Thyroxin TSH in target range&#xD;
        between 0.5 and 2.5 mIU/l&#xD;
&#xD;
        D) Patients with secondary hypothyroidism Pituitary disease with documented secondary&#xD;
        hypothyroidism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus (HbA1c &gt;6.5%)&#xD;
&#xD;
          -  Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure,&#xD;
             active cancer&#xD;
&#xD;
          -  Abuse of alcohol or illicit drugs&#xD;
&#xD;
          -  Women who are pregnant or breast feeding&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant&#xD;
&#xD;
          -  Previous enrolment into the current study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Betz, PD Dr. med.</last_name>
    <role>Study Director</role>
    <affiliation>Klinik Endokrinologie, Diabetes und Metabolismus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel, Department of Endocrinology</name>
      <address>
        <city>Basel</city>
        <state>BS</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypothyroidism</keyword>
  <keyword>Metabolomics</keyword>
  <keyword>Thyroid Hormones</keyword>
  <keyword>Hyperthyroidism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothyroidism</mesh_term>
    <mesh_term>Hyperthyroidism</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/NCT03823859
org study id: EKNZ 2018-01961
nct id: NCT03823859
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to develop a metabolome signature of thyroid hormone status. The
      metabolome signature could be useful in diagnosis and treatment of thyroid dysfunction
      diseases, especially in cases where TSH cannot be reliably used.
Primary Hypothyroidism is a frequent endocrine disorder, where the thyroid gland does not
      produce sufficient amounts of thyroid hormones. The substitution therapy is guided by
      measurement of the pituitary gland hormone thyrotropin (TSH). Patients with central
      hypothyroidism in whom pituitary insufficiency leads to hypothyroidism, TSH cannot be used to
      guide therapy. So far there are no reliable methods for therapy control in patients with
      central hypothyroidism.

      The measurement of small endogenous metabolites might give investigators a metabolomics
      profile. This could help to discriminate between euthyroid, hypothyroid and hyperthyroid
      state and therefore could be used for diagnosis and therapy control of thyroid dysfunction
      diseases.
observational model: Cohort
time perspective: Prospective
measure: Metabolome signature of thyroid Hormone Status (MSTH)
time frame: baseline/single visit
description: The MSTH will be tested against the current standard of diagnosis which is serum TSH level by multiple linear regression.
measure: Resting energy expenditure (REE)
time frame: baseline/single visit
description: Comparison of REE of healthy volunteers and Patients with thyroid dysfunction, measured by indirect calorimetry.
measure: Body composition concerning muscle mass
time frame: baseline/single visit
description: Comparison of muscle mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA
measure: Body composition concerning fat mass
time frame: baseline/single visit
description: Comparison of fat mass of healthy volunteers and patients with thyroid dysfunction, measured by DXA
arm group label: Healthy volunteers
description: Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)
Indirect calorimetry
Dual energy X-ray Absorptiometry (DXA)
arm group label: Patients with thyroid dysfunction
description: Patients with Primary hypothyroidism newly diagnosed, Primary hypothyroidism substituted, hyperthyroidism, secondary hypothyroidism
Blood sampling (fT3, fT4, TSH, Lipids, Glucose, HbA1c)
Indirect calorimetry
Dual energy X-ray Absorptiometry (DXA)
intervention type: Diagnostic Test
intervention name: Indirect calorimetry
description: Resting energy expenditure
arm group label: Healthy volunteers
arm group label: Patients with thyroid dysfunction
intervention type: Diagnostic Test
intervention name: Dual energy X-ray Absorptiometry (DXA)
description: Body composition
arm group label: Healthy volunteers
arm group label: Patients with thyroid dysfunction
intervention type: Diagnostic Test
intervention name: Blood sampling
description: fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel
arm group label: Healthy volunteers
arm group label: Patients with thyroid dysfunction
Serum and plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias Betz, PD Dr. med.
role: Study Director
affiliation: Klinik Endokrinologie, Diabetes und Metabolismus
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hypothyroidism
mesh term: Hyperthyroidism