xml: <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/NCT06035081</url>
    </required_header>
    <id_info>
      <org_study_id>1-10-72-83-22</org_study_id>
      <nct_id>NCT06035081</nct_id>
    </id_info>
    <brief_title>CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning</brief_title>
    <acronym>CIRCLE</acronym>
    <official_title>CIRcadian Rhythms and CortisoL. Effects on Substrate Metabolism and Clock Gene Expression and Functioning</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Aarhus</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aarhus University Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Aarhus</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 project is to study the effects of exogenous glucocorticoid exposure on&#xD;
        substrate metabolism, energy expenditure and correlates of circadian rhythmicity in healthy&#xD;
        adults. The hypotheses are:&#xD;
  &#xD;
        Short-term high dose glucocorticoid exposure in healthy subjects disrupts:&#xD;
  &#xD;
          -  The inherent circadian pattern of the respiratory exchange ratio and REE&#xD;
  &#xD;
          -  Sleep quality, appetite and food intake&#xD;
  &#xD;
          -  Clock gene expression and function in adipose tissue, skeletal muscle and blood&#xD;
             leukocytes&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</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>Basic Science</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Sleeping RER</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in respiratory exchange ratio (RER) during sleep between placebo and prednisolone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in TEE</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in Total Energy Expenditure between placebo and prednisolone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in REE</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in Resting Energy Expenditure between placebo and prednisolone and morning/evening</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in RER from fasting to feeding</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in respiratory exchange ratio (RER) after standard meal between placebo and prednisolone and morning/evening</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in PAEE</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in Physical Activity related Energy Expenditure (PAEE) between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in SEE</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in Sleeping Energy Expenditure (PAEE) between placebo and prednisolone</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in DIT</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in diet-induced thermogenesis between placebo and prednisolone and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in clock gene mRNA levels leukocytes</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in mRNA expression levels in blood leukocytes between placebo and prednisolone and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in clock gene mRNA levels adipose tissue</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in mRNA expression levels in adipose tissue biopsies between placebo and prednisolone and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in clock gene mRNA levels skeletal muscle</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Change in mRNA expression levels in skeletal muscle tissue biopsies between placebo and prednisolone and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in appetite</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by 10 point numerical rating scale before and after ad libitum meal and standard meal, and between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ad libitum food intake</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by caloric intake between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in food intake at home</measure>
      <time_frame>Intervention period 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by dietary registration during prednisolone and placebo</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fasting lipid oxidation rates</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in lipid oxidation rates from fasting to fed</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in glucose oxidation rates from fasting to fed</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fasting glucose oxidation rates</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in fasting protein oxidation rates</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in protein oxidation rates from fasting to fed</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ghrelin levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in LEAP-2 levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in GLP-1 levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in GIP levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Glucose levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Insulin levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Glucagon levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Gastrin levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in CCK levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in cortisol levels</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured successively over 24 hours in serum during study days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in FAP cells in skeletal muscle</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Fibro-adipogenic progenitor cells levels and characteristics in skeletal muscle tissue biopsies between placebo and prednisolone and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in FAP cells in adipose tissue</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Fibro-adipogenic progenitor cells levels and characteristics in adipose tissue biopsies between placebo and prednisolone and prednisolone and morning/evening</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in physical activity levels</measure>
      <time_frame>Intervention period 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by actigraph during study periods</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in IPAQ-7</measure>
      <time_frame>Intervention period 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by Internation Physical Activity Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sleep quality (measured)</measure>
      <time_frame>Intervention period 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by actigraph during study periods</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sleep quality (reported)</measure>
      <time_frame>Intervention period 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by Pittsburgh Sleep Quality Index questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in sleep quality</measure>
      <time_frame>Study day 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by polysomnography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HADS</measure>
      <time_frame>Intervention period 1 and 2 (7 weeks apart)</time_frame>
      <description>Measured by Hospital Anxiety and Depression Scale</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Prednisolone first, then placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Prednisolone 12.5 mg twice daily for 5 days. Placebo twice daily for 5 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo first, then prednisolone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Placebo twice daily for 5 days Prednisolone 12.5 mg twice daily for 5 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Prednisolone</intervention_name>
      <description>see arm description</description>
      <arm_group_label>Placebo first, then prednisolone</arm_group_label>
      <arm_group_label>Prednisolone first, then placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male sex&#xD;
  &#xD;
            -  BMI 20-30 kg/m2&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any chronic disease requiring daily medication excluding atopic skin or hay fever&#xD;
  &#xD;
            -  Alcohol consumption &gt;21 units per week&#xD;
  &#xD;
            -  Strong CYP3A4 inhibitors or inducers&#xD;
  &#xD;
            -  Use of glucocorticoid (GC) formulations: Inhaled corticosteroids, intra-articular or&#xD;
               intramuscular injections, steroid creams European steroid group IV-V used in the&#xD;
               genital area&#xD;
  &#xD;
            -  Permitted glucocorticoid formulations: eye-drops, nasal spray, GC creams European&#xD;
               steroid group I-III, and European steroid group IV-V used in the non-genital area only&#xD;
  &#xD;
            -  Shift work&#xD;
  &#xD;
            -  Severe claustrophobia&#xD;
  &#xD;
            -  Use of melatonin&#xD;
  &#xD;
            -  Previous diagnosis of a sleep disorder&#xD;
  &#xD;
            -  Known severe sleep apnea (&gt;30 respiration breaks/hour over 10 seconds)&#xD;
  &#xD;
            -  Deemed unable to complete the study safely by investigator&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jens Otto L Jørgensen, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Aarhus University Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Simon B Hansen, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aarhus University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Simon B Hansen, MD</last_name>
      <phone>41111574</phone>
      <phone_ext>+45</phone_ext>
      <email>simhan@clin.au.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jens Otto L Jørgensen, Professor</last_name>
      <email>joj@clin.au.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Endocrinology and Internal Medicine</name>
        <address>
          <city>Aarhus</city>
          <state>State</state>
          <zip>8200</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Simon B Hansen, MD</last_name>
        <phone>41111574</phone>
        <email>simhan@clin.au.dk</email>
      </contact>
      <investigator>
        <last_name>Simon B Hansen, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jelena Stankovic, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>glucocorticoids</keyword>
    <keyword>circadian rhythm</keyword>
    <keyword>metabolism</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prednisolone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035081
  org study id: 1-10-72-83-22
  nct id: NCT06035081
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this project is to study the effects of exogenous glucocorticoid exposure on
        substrate metabolism, energy expenditure and correlates of circadian rhythmicity in healthy
        adults. The hypotheses are:
  
        Short-term high dose glucocorticoid exposure in healthy subjects disrupts:
  
          -  The inherent circadian pattern of the respiratory exchange ratio and REE
  
          -  Sleep quality, appetite and food intake
  
          -  Clock gene expression and function in adipose tissue, skeletal muscle and blood
             leukocytes
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in Sleeping RER
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in respiratory exchange ratio (RER) during sleep between placebo and prednisolone
  measure: Change in TEE
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in Total Energy Expenditure between placebo and prednisolone
  measure: Change in REE
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in Resting Energy Expenditure between placebo and prednisolone and morning/evening
  measure: Change in RER from fasting to feeding
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in respiratory exchange ratio (RER) after standard meal between placebo and prednisolone and morning/evening
  measure: Change in PAEE
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in Physical Activity related Energy Expenditure (PAEE) between placebo and prednisolone and morning/evening
  measure: Change in SEE
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in Sleeping Energy Expenditure (PAEE) between placebo and prednisolone
  measure: Change in DIT
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in diet-induced thermogenesis between placebo and prednisolone and prednisolone and morning/evening
  measure: Change in clock gene mRNA levels leukocytes
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in mRNA expression levels in blood leukocytes between placebo and prednisolone and prednisolone and morning/evening
  measure: Change in clock gene mRNA levels adipose tissue
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in mRNA expression levels in adipose tissue biopsies between placebo and prednisolone and prednisolone and morning/evening
  measure: Change in clock gene mRNA levels skeletal muscle
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Change in mRNA expression levels in skeletal muscle tissue biopsies between placebo and prednisolone and prednisolone and morning/evening
  measure: Change in appetite
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured by 10 point numerical rating scale before and after ad libitum meal and standard meal, and between placebo and prednisolone and morning/evening
  measure: Change in ad libitum food intake
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured by caloric intake between placebo and prednisolone and morning/evening
  measure: Change in food intake at home
  time frame: Intervention period 1 and 2 (7 weeks apart)
  description: Measured by dietary registration during prednisolone and placebo
  measure: Change in fasting lipid oxidation rates
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
  measure: Change in lipid oxidation rates from fasting to fed
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
  measure: Change in glucose oxidation rates from fasting to fed
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
  measure: Change in fasting glucose oxidation rates
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
  measure: Change in fasting protein oxidation rates
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
  measure: Change in protein oxidation rates from fasting to fed
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured by whole room Indirect calorimetry between placebo and prednisolone and morning/evening
  measure: Change in ghrelin levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
  measure: Change in LEAP-2 levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
  measure: Change in GLP-1 levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
  measure: Change in GIP levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
  measure: Change in Glucose levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
  measure: Change in Insulin levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
  measure: Change in Glucagon levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
  measure: Change in Gastrin levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
  measure: Change in CCK levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured in serum before and after ad libitum meals and standard meals; between placebo and prednisolone and morning/evening
  measure: Change in cortisol levels
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured successively over 24 hours in serum during study days
  measure: Change in FAP cells in skeletal muscle
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Fibro-adipogenic progenitor cells levels and characteristics in skeletal muscle tissue biopsies between placebo and prednisolone and prednisolone and morning/evening
  measure: Change in FAP cells in adipose tissue
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Fibro-adipogenic progenitor cells levels and characteristics in adipose tissue biopsies between placebo and prednisolone and prednisolone and morning/evening
  measure: Change in physical activity levels
  time frame: Intervention period 1 and 2 (7 weeks apart)
  description: Measured by actigraph during study periods
  measure: Change in IPAQ-7
  time frame: Intervention period 1 and 2 (7 weeks apart)
  description: Measured by Internation Physical Activity Questionnaire
  measure: Change in sleep quality (measured)
  time frame: Intervention period 1 and 2 (7 weeks apart)
  description: Measured by actigraph during study periods
  measure: Change in sleep quality (reported)
  time frame: Intervention period 1 and 2 (7 weeks apart)
  description: Measured by Pittsburgh Sleep Quality Index questionnaire
  measure: Change in sleep quality
  time frame: Study day 1 and 2 (7 weeks apart)
  description: Measured by polysomnography
  measure: Change in HADS
  time frame: Intervention period 1 and 2 (7 weeks apart)
  description: Measured by Hospital Anxiety and Depression Scale
  arm group label: Prednisolone first, then placebo
  arm group type: Experimental
  description: Prednisolone 12.5 mg twice daily for 5 days. Placebo twice daily for 5 days
  arm group label: Placebo first, then prednisolone
  arm group type: Experimental
  description: Placebo twice daily for 5 days Prednisolone 12.5 mg twice daily for 5 days.
  intervention type: Drug
  intervention name: Prednisolone
  description: see arm description
  arm group label: Placebo first, then prednisolone
  arm group label: Prednisolone first, then placebo
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jens Otto L Jørgensen, Professor
  role: Study Director
  affiliation: Aarhus University Hospital
  last name: Simon B Hansen, MD
  role: Principal Investigator
  affiliation: Aarhus University Hospital
  last name: Simon B Hansen, MD
  phone: 41111574
  phone ext: +45
  email: simhan@clin.au.dk
  last name: Jens Otto L Jørgensen, Professor
  email: joj@clin.au.dk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Denmark
  responsible party type: Sponsor
  mesh term: Prednisolone
  sharing ipd: No