<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/NCT03012113</url>
  </required_header>
  <id_info>
    <org_study_id>P16.023</org_study_id>
    <nct_id>NCT03012113</nct_id>
  </id_info>
  <brief_title>Mirabegron and Brown Adipose Tissue</brief_title>
  <acronym>Mirab</acronym>
  <official_title>The Effect of Mirabegron on Brown Adipose Tissue in Healthy Young White Caucasian and South Asian Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ingrid Jazet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Leiden University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity and type 2 diabetes (T2D) are emerging problems worldwide. In particular South Asian&#xD;
      individuals (representing 20% of the world population) have an increased risk of obesity and&#xD;
      related disorders. They are at higher risk for the development of T2D as compared to white&#xD;
      Caucasians and develop T2D at a younger age and with lower BMI. The underlying mechanisms&#xD;
      that might explain these ethnical differences have not been clarified or understood yet. As a&#xD;
      consequence, treatment options are limited and unfocussed, and novel specific strategies are&#xD;
      needed.&#xD;
&#xD;
      Brown adipose tissue (BAT) has recently been discovered as a major player in energy&#xD;
      metabolism in humans. In a process known as thermogenesis, BAT takes up fatty acids (FA) and&#xD;
      glucose from the circulation and subsequently combusts FA and glucose into heat, thereby&#xD;
      increasing energy expenditure and improving glucose and FA metabolism. Using&#xD;
      18F-fluorodeoxyglucose (18F-FDG) (positron emission tomography/computed tomography) PET-CT&#xD;
      scan analysis investigators have recently shown that South Asian individuals have less brown&#xD;
      adipose tissue (BAT) than white Caucasians. This might suggest that they have a lower energy&#xD;
      metabolism, which could underlie their increased predisposition for obesity and the&#xD;
      development of T2D.&#xD;
&#xD;
      Activation of BAT, for example by cold exposure, was shown to have beneficial metabolic&#xD;
      effects in humans. Cold acclimatization can increase BAT volume, nonshivering thermogenesis,&#xD;
      glucose uptake by BAT, as well as decrease fat mass in healthy young men. Therefore&#xD;
      activation of BAT is considered as a novel therapeutic target in the treatment of obesity and&#xD;
      T2D. As cold exposure is not the most desired therapeutic strategy for humans, current&#xD;
      pre-clinical research focuses on pharmacological activation of BAT.&#xD;
&#xD;
      β3-receptor agonists can be used to mimic sympathetic innervation of BAT. Our recent studies&#xD;
      using mice with a human-like lipoprotein profile showed that treatment with a β3-receptor&#xD;
      agonist decreased fat mass, improved dyslipidemia, increased insulin sensitivity and even&#xD;
      attenuated the development of atherosclerosis. Likewise, the novel β3-receptor agonist&#xD;
      (Mirabegron) has recently been shown to activate BAT in healthy young men as effectively as&#xD;
      cold exposure. Therefore, ß3-receptor agonism would be a promising treatment option to&#xD;
      activate BAT and enhance energy expenditure, especially for South Asians.&#xD;
&#xD;
      Currently the most common way to visualize BAT in humans is by 18F-FDG PET-CT scan. However&#xD;
      this method is both expensive and invasive, as it uses ionizing radiation. Recently, MRI,&#xD;
      which has no radiation burden, has emerged as a novel method to visualize BAT in humans.&#xD;
      Activation of BAT results in combustion of intracellular lipid stores, which eventually leads&#xD;
      to a lower triglyceride (TG) content. MRI can measure TG content of tissue, and using MRI&#xD;
      technology the activation of BAT can be quantified by the relative reduction in the TG&#xD;
      content of BAT. The use of MRI to visualize and quantify BAT activity is a safe,&#xD;
      cost-effective and innovative alternative to PET-CT, which has a potential to become a new&#xD;
      gold standard in the nearby future.&#xD;
&#xD;
      To investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic&#xD;
      phenotype of South Asians, investigators will perform a randomized cross-over study in which&#xD;
      20 healthy young men aged 18-30 years with a lean body type (BMI &lt;25 kg/m2) are included.&#xD;
      Dutch South Asian individuals (n=10) and matched Dutch white Caucasian individuals (n=10)&#xD;
      will participate in a cross-over study consisting of three different regimes.&#xD;
&#xD;
      This study will investigate whether β3-receptor agonism has therapeutic potential to improve&#xD;
      the metabolic phenotype of South Asians. The effects of a β3-receptor agonist on BAT activity&#xD;
      in South Asians have never been studied before. Elucidating the effects of this β3-receptor&#xD;
      agonist on BAT activity in South Asians might have major clinical implications, as it might&#xD;
      result in the discovery of a potential novel treatment strategy to combat obesity and T2D in&#xD;
      this especially vulnerable population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the current study, the effect of one single dose of Mirabegron (200 mg) versus placebo and&#xD;
      cold-exposure will be studied in health young (18-30 years) Dutch South Asian (n=10) and&#xD;
      Dutch Caucasian (n=10) men.&#xD;
&#xD;
      All study subjects will be screened. If the subject meets all the inclusion criteria, is&#xD;
      willing to participate in the study and has signed the informed consent, he will be included.&#xD;
      All subjects will be asked not to make any changes in their usual diets and physical&#xD;
      activities before the start of the whole study.&#xD;
&#xD;
      At screening a thorough medical history and physical examination will be performed. Subjects&#xD;
      will be examined while in the fasting state. Anthropometric measurements will be performed as&#xD;
      well as a BIA measurement for determination of body fat percentage and basal blood sample&#xD;
      will be taken by means of a venapunction. Basal blood measurements include kidney, liver,&#xD;
      thyroid, hemoglobulin, natrium, kalium, ureum and lipid parameters as well as glucose&#xD;
      concentrations.&#xD;
&#xD;
      If subjects are eligible to participate they first will complete Study day 1, on which we&#xD;
      will measure BAT activity and volume before and after cold exposure. Subject will undergo a&#xD;
      baseline oxycon and finapres measurement to determine REE and blood pressure and heart rate&#xD;
      (30 min). After this a baseline MRI scan will be made followed by an individualized cooling&#xD;
      protocol so that the maximum non-shivering thermogenesis is reached. During the cold&#xD;
      exposure, skin temperature will be measured via 'iButtons'. One iButtons will be placed under&#xD;
      the armpit as an approximation of the 'core temperature'. When shivering temperature is&#xD;
      reached, stable cooling period will start (t=0). After 30 minutes of stable cold exposure&#xD;
      (t=30) REE and blood pressure and heart rate will be analyzed a second time using a&#xD;
      ventilated hood system and the finapres. Thereafter (t=60) BAT activity and volume will be&#xD;
      measured using a second MRI scan. Furthermore, during the cooling procedure a venous blood&#xD;
      sample will be obtained every 15 minutes to monitor dynamic changes in plasma lipids. In&#xD;
      addition, plasma catecholamine concentrations will be determined. If there is no increased&#xD;
      BAT activity upon cold stimulation the subject will be excluded from further participation in&#xD;
      the study. If there is detectable BAT activity on Study day 1, subjects will participate in&#xD;
      Study days 2 and 3 and will be randomized to receive first Mirabegron or placebo to minimize&#xD;
      bias.&#xD;
&#xD;
      On study day 2 first baseline oxycon and finapres measurements will be performed to determine&#xD;
      REE and blood pressure and heart rate (30 min). Thereafter, the subject will receive a single&#xD;
      dose of 200 mg Mirabegron (four tables of 50 mg) (or placebo) (t=0). Again skin temperature&#xD;
      will be measured via 'iButtons'. One iButton will be placed under the armpit as an&#xD;
      approximation of the 'core temperature'. After 1, 2 and 3 hours (t=60, t=120 and t=180) REE&#xD;
      is analyzed using a ventilated hood system and blood pressure and heart rate are monitored&#xD;
      using the finapres. Thereafter, 3.5 hours after the administration of the compound (t=210)&#xD;
      BAT activity and volume will be determined using an MRI scan. Furthermore, a venous blood&#xD;
      sample will be drawn every 15 minutes to monitor changes in plasma lipids. In addition,&#xD;
      plasma catecholamine concentrations will be determined.Study day 3 is exactly the same as&#xD;
      study day 2, except this time the subject will receive the other compound (either 200 mg&#xD;
      Mirabegron or placebo).&#xD;
&#xD;
      All study days will take place at the Leiden University Medical Centre (LUMC). Between study&#xD;
      days 2 and 3 a wash-out period of 13 days will be maintained to make sure that the drug is&#xD;
      out of the body during the next exam.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of Mirabegron treatment on BAT activity measured by MRI in South Asians compared with white Caucasians.</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Brown adipose tissue activity will be measured by means of MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of Mirabegron treatment on REE between South Asian and white Caucasian individuals.</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Indirect calorimetry will be performed to asses resting energy expenditure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mild cold exposure and Mirabegron on plasma lipoprotein profiles</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Use NMR to analyse lipoproteins in venous blood samples taken during the cooling protocol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mirabegron treatment on plasma lipid levels between South Asian and white Caucasian individuals.</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Use enzymatic assays to determine lipid levels in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The effect of Mirabegron treatment on sympathetic output in South Asian and white Caucasian individuals.</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Measure noradrenalin and adrenaline levels in plasma</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Short term mild cooling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will undergo a short term mild cooling protocol consisting of personalized water cooling method for approximately 2 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirabegron</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive one dosage of 200 mg Mirabegron (Astellas Pharma).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive one dosage of Placebo, which is packed and labeled to mach the active compound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirabegron</intervention_name>
    <arm_group_label>Mirabegron</arm_group_label>
    <other_name>Betmiga</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Short term mild cooling</intervention_name>
    <arm_group_label>Short term mild cooling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male volunteers. 10 white Caucasians, born in the Netherlands. 10 South Asians, living&#xD;
             in the Netherlands.&#xD;
&#xD;
          -  Age: 18-30 years&#xD;
&#xD;
          -  BMI ≤ 25 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 25 kg/m2&#xD;
&#xD;
          -  Recent excessive weight loss or exercise&#xD;
&#xD;
          -  Alcohol and/ or drugs abuse&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Any significant chronic disease, including diabetes&#xD;
&#xD;
          -  Renal, hepatic or endocrine disease&#xD;
&#xD;
          -  Heart disease or arrhythmias&#xD;
&#xD;
          -  Thyroid disease or thyroid medication&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Use of medication known to influence glucose and/or lipid metabolism or BAT activity&#xD;
             (e.g. beta blockers or calcium channel blockers)&#xD;
&#xD;
          -  Use of drugs that influence cardiac function or affect QT time&#xD;
&#xD;
          -  Use of MAO inhibitor&#xD;
&#xD;
          -  Use of systemic corticosteroids in previous six weeks&#xD;
&#xD;
          -  Recent participation in other research projects (within the last 3 months),&#xD;
             participation in 2 or more projects in one year&#xD;
&#xD;
          -  Contraindications for undergoing an MRI scan:&#xD;
&#xD;
          -  Presence of non-MR safe metal implants or objects in the body.&#xD;
&#xD;
          -  Pacemaker, neurostimulator, hydrocephalus pump, drug pump, non-removable hearing aid,&#xD;
             large recent tattoos.&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Tinnitus or hyperacusis&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrid Jazet, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ingrid Jazet, MD</last_name>
    <phone>+31 75262997</phone>
    <email>i.m.jazet@lumc.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <state>Zuid-Holland</state>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ingrid Jazet, MD, PhD</last_name>
      <phone>+33-715268161</phone>
      <email>i.m.jazet@lumc.nl</email>
    </contact>
    <contact_backup>
      <last_name>Mariëtte Boon, PhD</last_name>
      <phone>+31-715265462</phone>
      <email>m.r.boon@lumc.nl</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
    <investigator_full_name>Ingrid Jazet</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Adipose tissue</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mirabegron</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/NCT03012113
org study id: P16.023
nct id: NCT03012113
lead sponsor: 
has dmc: Yes
Obesity and type 2 diabetes (T2D) are emerging problems worldwide. In particular South Asian
      individuals (representing 20% of the world population) have an increased risk of obesity and
      related disorders. They are at higher risk for the development of T2D as compared to white
      Caucasians and develop T2D at a younger age and with lower BMI. The underlying mechanisms
      that might explain these ethnical differences have not been clarified or understood yet. As a
      consequence, treatment options are limited and unfocussed, and novel specific strategies are
      needed.

      Brown adipose tissue (BAT) has recently been discovered as a major player in energy
      metabolism in humans. In a process known as thermogenesis, BAT takes up fatty acids (FA) and
      glucose from the circulation and subsequently combusts FA and glucose into heat, thereby
      increasing energy expenditure and improving glucose and FA metabolism. Using
      18F-fluorodeoxyglucose (18F-FDG) (positron emission tomography/computed tomography) PET-CT
      scan analysis investigators have recently shown that South Asian individuals have less brown
      adipose tissue (BAT) than white Caucasians. This might suggest that they have a lower energy
      metabolism, which could underlie their increased predisposition for obesity and the
      development of T2D.

      Activation of BAT, for example by cold exposure, was shown to have beneficial metabolic
      effects in humans. Cold acclimatization can increase BAT volume, nonshivering thermogenesis,
      glucose uptake by BAT, as well as decrease fat mass in healthy young men. Therefore
      activation of BAT is considered as a novel therapeutic target in the treatment of obesity and
      T2D. As cold exposure is not the most desired therapeutic strategy for humans, current
      pre-clinical research focuses on pharmacological activation of BAT.

      β3-receptor agonists can be used to mimic sympathetic innervation of BAT. Our recent studies
      using mice with a human-like lipoprotein profile showed that treatment with a β3-receptor
      agonist decreased fat mass, improved dyslipidemia, increased insulin sensitivity and even
      attenuated the development of atherosclerosis. Likewise, the novel β3-receptor agonist
      (Mirabegron) has recently been shown to activate BAT in healthy young men as effectively as
      cold exposure. Therefore, ß3-receptor agonism would be a promising treatment option to
      activate BAT and enhance energy expenditure, especially for South Asians.

      Currently the most common way to visualize BAT in humans is by 18F-FDG PET-CT scan. However
      this method is both expensive and invasive, as it uses ionizing radiation. Recently, MRI,
      which has no radiation burden, has emerged as a novel method to visualize BAT in humans.
      Activation of BAT results in combustion of intracellular lipid stores, which eventually leads
      to a lower triglyceride (TG) content. MRI can measure TG content of tissue, and using MRI
      technology the activation of BAT can be quantified by the relative reduction in the TG
      content of BAT. The use of MRI to visualize and quantify BAT activity is a safe,
      cost-effective and innovative alternative to PET-CT, which has a potential to become a new
      gold standard in the nearby future.

      To investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic
      phenotype of South Asians, investigators will perform a randomized cross-over study in which
      20 healthy young men aged 18-30 years with a lean body type (BMI <25 kg/m2) are included.
      Dutch South Asian individuals (n=10) and matched Dutch white Caucasian individuals (n=10)
      will participate in a cross-over study consisting of three different regimes.

      This study will investigate whether β3-receptor agonism has therapeutic potential to improve
      the metabolic phenotype of South Asians. The effects of a β3-receptor agonist on BAT activity
      in South Asians have never been studied before. Elucidating the effects of this β3-receptor
      agonist on BAT activity in South Asians might have major clinical implications, as it might
      result in the discovery of a potential novel treatment strategy to combat obesity and T2D in
      this especially vulnerable population.
In the current study, the effect of one single dose of Mirabegron (200 mg) versus placebo and
      cold-exposure will be studied in health young (18-30 years) Dutch South Asian (n=10) and
      Dutch Caucasian (n=10) men.

      All study subjects will be screened. If the subject meets all the inclusion criteria, is
      willing to participate in the study and has signed the informed consent, he will be included.
      All subjects will be asked not to make any changes in their usual diets and physical
      activities before the start of the whole study.

      At screening a thorough medical history and physical examination will be performed. Subjects
      will be examined while in the fasting state. Anthropometric measurements will be performed as
      well as a BIA measurement for determination of body fat percentage and basal blood sample
      will be taken by means of a venapunction. Basal blood measurements include kidney, liver,
      thyroid, hemoglobulin, natrium, kalium, ureum and lipid parameters as well as glucose
      concentrations.

      If subjects are eligible to participate they first will complete Study day 1, on which we
      will measure BAT activity and volume before and after cold exposure. Subject will undergo a
      baseline oxycon and finapres measurement to determine REE and blood pressure and heart rate
      (30 min). After this a baseline MRI scan will be made followed by an individualized cooling
      protocol so that the maximum non-shivering thermogenesis is reached. During the cold
      exposure, skin temperature will be measured via 'iButtons'. One iButtons will be placed under
      the armpit as an approximation of the 'core temperature'. When shivering temperature is
      reached, stable cooling period will start (t=0). After 30 minutes of stable cold exposure
      (t=30) REE and blood pressure and heart rate will be analyzed a second time using a
      ventilated hood system and the finapres. Thereafter (t=60) BAT activity and volume will be
      measured using a second MRI scan. Furthermore, during the cooling procedure a venous blood
      sample will be obtained every 15 minutes to monitor dynamic changes in plasma lipids. In
      addition, plasma catecholamine concentrations will be determined. If there is no increased
      BAT activity upon cold stimulation the subject will be excluded from further participation in
      the study. If there is detectable BAT activity on Study day 1, subjects will participate in
      Study days 2 and 3 and will be randomized to receive first Mirabegron or placebo to minimize
      bias.

      On study day 2 first baseline oxycon and finapres measurements will be performed to determine
      REE and blood pressure and heart rate (30 min). Thereafter, the subject will receive a single
      dose of 200 mg Mirabegron (four tables of 50 mg) (or placebo) (t=0). Again skin temperature
      will be measured via 'iButtons'. One iButton will be placed under the armpit as an
      approximation of the 'core temperature'. After 1, 2 and 3 hours (t=60, t=120 and t=180) REE
      is analyzed using a ventilated hood system and blood pressure and heart rate are monitored
      using the finapres. Thereafter, 3.5 hours after the administration of the compound (t=210)
      BAT activity and volume will be determined using an MRI scan. Furthermore, a venous blood
      sample will be drawn every 15 minutes to monitor changes in plasma lipids. In addition,
      plasma catecholamine concentrations will be determined.Study day 3 is exactly the same as
      study day 2, except this time the subject will receive the other compound (either 200 mg
      Mirabegron or placebo).

      All study days will take place at the Leiden University Medical Centre (LUMC). Between study
      days 2 and 3 a wash-out period of 13 days will be maintained to make sure that the drug is
      out of the body during the next exam.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The effect of Mirabegron treatment on BAT activity measured by MRI in South Asians compared with white Caucasians.
time frame: Up to 1 year
description: Brown adipose tissue activity will be measured by means of MRI
measure: Effect of Mirabegron treatment on REE between South Asian and white Caucasian individuals.
time frame: Up to 1 year
description: Indirect calorimetry will be performed to asses resting energy expenditure
measure: Mild cold exposure and Mirabegron on plasma lipoprotein profiles
time frame: Up to 1 year
description: Use NMR to analyse lipoproteins in venous blood samples taken during the cooling protocol
measure: Mirabegron treatment on plasma lipid levels between South Asian and white Caucasian individuals.
time frame: Up to 1 year
description: Use enzymatic assays to determine lipid levels in plasma
measure: The effect of Mirabegron treatment on sympathetic output in South Asian and white Caucasian individuals.
time frame: Up to 1 year
description: Measure noradrenalin and adrenaline levels in plasma
arm group label: Short term mild cooling
arm group type: Other
description: Subjects will undergo a short term mild cooling protocol consisting of personalized water cooling method for approximately 2 hours.
arm group label: Mirabegron
arm group type: Active Comparator
description: Subjects will receive one dosage of 200 mg Mirabegron (Astellas Pharma).
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will receive one dosage of Placebo, which is packed and labeled to mach the active compound.
intervention type: Drug
intervention name: Mirabegron
arm group label: Mirabegron
other name: Betmiga
intervention type: Other
intervention name: Short term mild cooling
arm group label: Short term mild cooling
intervention type: Drug
intervention name: Placebo Oral Capsule
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ingrid Jazet, MD
role: Principal Investigator
affiliation: Leiden University Medical Center
last name: Ingrid Jazet, MD
phone: +31 75262997
email: i.m.jazet@lumc.nl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: Leiden University Medical Center
investigator full name: Ingrid Jazet
investigator title: Dr
mesh term: Mirabegron