<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/NCT02993562</url>
  </required_header>
  <id_info>
    <org_study_id>Herlev-Gentofte Hypomafia</org_study_id>
    <nct_id>NCT02993562</nct_id>
  </id_info>
  <brief_title>Hypothyroidism, Metabolism and Food Intake</brief_title>
  <acronym>Hypomafia</acronym>
  <official_title>Levothyroxine Substitution Therapy in Hypothyroid Patients - Impact on Appetite and Food Intake</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center for Diabetes Research, Herlev and Gentofte Hospital.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Herlev Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project has the following primary aims:&#xD;
&#xD;
      To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during&#xD;
      the first six months after starting levothyroxine (L-T4) substitution therapy&#xD;
&#xD;
      Secondary aims are:&#xD;
&#xD;
      To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body&#xD;
      mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut&#xD;
      and pancreatic hormone responses, gastric and gall bladder emptying, resting energy&#xD;
      expenditure (REE), quality of life (QOL) and cognitive function&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      18 newly diagnosed hypothyroid female patients and 18 healthy controls age between 20 and 75&#xD;
      years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the&#xD;
      general practitioners before start of substitution therapy.&#xD;
&#xD;
      The study is devided in to three identical experimental days of approx. 6 hours. First&#xD;
      experimental day placed before T4 treatment is initiated. Second day as soon as Thyroid&#xD;
      Stimulating Hormone (TSH) is below 4 milli unit pr liter (mU/l). The Third experimental day&#xD;
      after 6 months of T4 therapy.&#xD;
&#xD;
      For 5-7 days before each experimental day, the participants' physical activity energy&#xD;
      expenditure (PAEE) will be monitored by an Actiheart® pedometer attached to the skin of the&#xD;
      chest.&#xD;
&#xD;
      The last two days before each experimental day, the participants will follow a standardised&#xD;
      diet following World Health Organization guidelines on energy requirements and nutrient&#xD;
      composition according to gender, age and body weight Shortly after diagnosis patients will&#xD;
      undergo a test panel at the first experimental day, where patients arrives fasting.&#xD;
&#xD;
      Visual analog score on satiety and thirst will be filled out continuously. REE will be&#xD;
      measured by a CCM-express calorimeter,&#xD;
&#xD;
        -  Dual Energy X-ray absorptiometry (DEXA)-scan&#xD;
&#xD;
        -  Blood samples will be taken continuously during the experimental day. Gall bladder size&#xD;
           will be examined at 6 times during the experimental day using ultra sound.&#xD;
&#xD;
      At the end of the day, patients´ satiety will be examined with an ad libitum meal.&#xD;
&#xD;
      Blood will be analysed for Gastric inhibitory polypeptide (GIP), Glucagon-like Peptide 1&#xD;
      (GLP-1), Glucagon-like Peptide 2 (GLP-2), glucagon, peptide tyrosine tyrosine (PYY), Gastrin,&#xD;
      Cholesystokinin (CCK), Insulin, C-peptide, Blood sugar, Cholesterol, Free fatty acids and&#xD;
      paracetamol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">August 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in food intake at ad libitum meal</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in food intake at ad libitum meal measured at each experimental day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satiety</measure>
    <time_frame>6 months</time_frame>
    <description>Satiety measured on a visual analog score 13 times during each experimental day.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in lean mass assessed through lean mass</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in lean mass assessed through lean mass with DEXA-scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fat mass assessed through lean mass with DEXA-scan</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in lean mass assessed through lean mass with DEXA-scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in gall bladder emptying</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in gall bladder emptying evaluated with ultrasound 6 times each experimental day before and after meal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in resting energy expenditure</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in resting energy expenditure measured 3 times each experimental day using Indirect Calorimetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood sugar response to standardized meal.</measure>
    <time_frame>6 Months</time_frame>
    <description>changes in blood sugar response to standardized meal measured before and after meal at each experimental day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in stomach emptying</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluated with continously measuring serum paracetamol after standardized meal containing 1,5 g paracetamol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in GIP hormones</measure>
    <time_frame>6 months</time_frame>
    <description>Continously measuring of a range of hormones during each experimental day: GIP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in GLP-1 hormones</measure>
    <time_frame>6 months</time_frame>
    <description>Continously measuring of GLP-1 hormones during each experimental day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in GLP-2 hormones</measure>
    <time_frame>6 Months</time_frame>
    <description>Continuously measuring of GLP-2 hormones during each experimental day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in PYY hormones</measure>
    <time_frame>6 Months</time_frame>
    <description>Continuously measuring of PYY hormones during each experimental day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in CCK hormones</measure>
    <time_frame>6 Months</time_frame>
    <description>Continuously measuring of CCK hormones during each experimental day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Gastrin hormones</measure>
    <time_frame>6 Months</time_frame>
    <description>Continuously measuring of Gastrin during each experimental day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Insulin hormones</measure>
    <time_frame>6 Months</time_frame>
    <description>Continuously measuring of Insulin during each experimental day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Glucagon</measure>
    <time_frame>6 Months</time_frame>
    <description>Continuously measuring of Glucagon during each experimental day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in C-peptide</measure>
    <time_frame>6 Months</time_frame>
    <description>Continuously measuring of C-peptide during each experimental day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Free-Fatty acids</measure>
    <time_frame>6 Months</time_frame>
    <description>Continuously measuring of Free Fatty acids during each experimental day</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">18</enrollment>
  <condition>Hypothyroidism</condition>
  <arm_group>
    <arm_group_label>Hypothyroid patients</arm_group_label>
    <description>Hypothyroid patients treated with Levothyroxine as part of normal treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Matched on age and BMI. 18 Persons.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levothyroxine</intervention_name>
    <description>Normal treatment with levothyroxine.</description>
    <arm_group_label>Hypothyroid patients</arm_group_label>
    <other_name>Eltroxin/Euthyrox</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        18 Hypothyroid female patients with a TSH &gt; 10 without Levothyroxine treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  TSH &gt; 10&#xD;
&#xD;
          -  Female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Competing serious disease&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Not able to understand written and spoken danish&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Thyroidectomized patients&#xD;
&#xD;
          -  Amiodarone treatment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bjarke B Medici, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Internal Medicine, Herlev and Gentofte hospitals.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Diabetes Research, Herlev and Gentofte Hospitals</name>
      <address>
        <city>Copenhagen</city>
        <state>Region Hovedstaden</state>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>November 5, 2018</last_update_submitted>
  <last_update_submitted_qc>November 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Bjarke Borregaard Medici</investigator_full_name>
    <investigator_title>Principial Investigator</investigator_title>
  </responsible_party>
  <keyword>Food intake</keyword>
  <keyword>Resting Energy Expenditure</keyword>
  <keyword>Gall Bladder emptying</keyword>
  <keyword>Insulin response</keyword>
  <keyword>Body Composition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothyroidism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02993562
org study id: Herlev-Gentofte Hypomafia
nct id: NCT02993562
lead sponsor: 
collaborator: 
has dmc: No
This project has the following primary aims:

      To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during
      the first six months after starting levothyroxine (L-T4) substitution therapy

      Secondary aims are:

      To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body
      mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut
      and pancreatic hormone responses, gastric and gall bladder emptying, resting energy
      expenditure (REE), quality of life (QOL) and cognitive function
18 newly diagnosed hypothyroid female patients and 18 healthy controls age between 20 and 75
      years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the
      general practitioners before start of substitution therapy.

      The study is devided in to three identical experimental days of approx. 6 hours. First
      experimental day placed before T4 treatment is initiated. Second day as soon as Thyroid
      Stimulating Hormone (TSH) is below 4 milli unit pr liter (mU/l). The Third experimental day
      after 6 months of T4 therapy.

      For 5-7 days before each experimental day, the participants' physical activity energy
      expenditure (PAEE) will be monitored by an Actiheart® pedometer attached to the skin of the
      chest.

      The last two days before each experimental day, the participants will follow a standardised
      diet following World Health Organization guidelines on energy requirements and nutrient
      composition according to gender, age and body weight Shortly after diagnosis patients will
      undergo a test panel at the first experimental day, where patients arrives fasting.

      Visual analog score on satiety and thirst will be filled out continuously. REE will be
      measured by a CCM-express calorimeter,

        -  Dual Energy X-ray absorptiometry (DEXA)-scan

        -  Blood samples will be taken continuously during the experimental day. Gall bladder size
           will be examined at 6 times during the experimental day using ultra sound.

      At the end of the day, patients´ satiety will be examined with an ad libitum meal.

      Blood will be analysed for Gastric inhibitory polypeptide (GIP), Glucagon-like Peptide 1
      (GLP-1), Glucagon-like Peptide 2 (GLP-2), glucagon, peptide tyrosine tyrosine (PYY), Gastrin,
      Cholesystokinin (CCK), Insulin, C-peptide, Blood sugar, Cholesterol, Free fatty acids and
      paracetamol.
observational model: Case-Control
time perspective: Prospective
measure: Changes in food intake at ad libitum meal
time frame: 6 months
description: Changes in food intake at ad libitum meal measured at each experimental day
measure: Satiety
time frame: 6 months
description: Satiety measured on a visual analog score 13 times during each experimental day.
measure: Changes in lean mass assessed through lean mass
time frame: 6 months
description: Changes in lean mass assessed through lean mass with DEXA-scan
measure: Changes in fat mass assessed through lean mass with DEXA-scan
time frame: 6 months
description: Changes in lean mass assessed through lean mass with DEXA-scan
measure: Changes in gall bladder emptying
time frame: 6 months
description: Changes in gall bladder emptying evaluated with ultrasound 6 times each experimental day before and after meal.
measure: Changes in resting energy expenditure
time frame: 6 months
description: Changes in resting energy expenditure measured 3 times each experimental day using Indirect Calorimetry.
measure: Changes in blood sugar response to standardized meal.
time frame: 6 Months
description: changes in blood sugar response to standardized meal measured before and after meal at each experimental day.
measure: Changes in stomach emptying
time frame: 6 months
description: Evaluated with continously measuring serum paracetamol after standardized meal containing 1,5 g paracetamol.
measure: Changes in GIP hormones
time frame: 6 months
description: Continously measuring of a range of hormones during each experimental day: GIP
measure: Changes in GLP-1 hormones
time frame: 6 months
description: Continously measuring of GLP-1 hormones during each experimental day
measure: Changes in GLP-2 hormones
time frame: 6 Months
description: Continuously measuring of GLP-2 hormones during each experimental day
measure: Changes in PYY hormones
time frame: 6 Months
description: Continuously measuring of PYY hormones during each experimental day
measure: Changes in CCK hormones
time frame: 6 Months
description: Continuously measuring of CCK hormones during each experimental day
measure: Changes in Gastrin hormones
time frame: 6 Months
description: Continuously measuring of Gastrin during each experimental day
measure: Changes in Insulin hormones
time frame: 6 Months
description: Continuously measuring of Insulin during each experimental day
measure: Changes in Glucagon
time frame: 6 Months
description: Continuously measuring of Glucagon during each experimental day
measure: Changes in C-peptide
time frame: 6 Months
description: Continuously measuring of C-peptide during each experimental day
measure: Changes in Free-Fatty acids
time frame: 6 Months
description: Continuously measuring of Free Fatty acids during each experimental day
arm group label: Hypothyroid patients
description: Hypothyroid patients treated with Levothyroxine as part of normal treatment.
arm group label: Healthy volunteers
description: Matched on age and BMI. 18 Persons.
intervention type: Drug
intervention name: Levothyroxine
description: Normal treatment with levothyroxine.
arm group label: Hypothyroid patients
other name: Eltroxin/Euthyrox
Blood Urine
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bjarke B Medici, MD
role: Principal Investigator
affiliation: Department of Internal Medicine, Herlev and Gentofte hospitals.
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev Hospital
investigator full name: Bjarke Borregaard Medici
investigator title: Principial Investigator
mesh term: Hypothyroidism
sharing ipd: No