<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/NCT03000231</url>
  </required_header>
  <id_info>
    <org_study_id>14-1484</org_study_id>
    <nct_id>NCT03000231</nct_id>
  </id_info>
  <brief_title>Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency</brief_title>
  <official_title>Circadian Function and Cardio-metabolic Risk in Adrenal Insufficiency: a Case Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare cardio-metabolic risk, glucose tolerance, and night&#xD;
      time blood pressure between healthy control subjects and patients with adrenal insufficiency.&#xD;
      No intervention will be administered and the study is observational only.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We propose to use a case control design to test the main hypothesis that as compared to&#xD;
      healthy control subjects matched for sex, age, adiposity and race/ethnicity, patients with&#xD;
      adrenal insufficiency, whether primary or secondary, have disturbances of the circadian&#xD;
      system that are associated with high day to day variability of sleep time as well as elevated&#xD;
      markers of cardio-metabolic risk, including abnormal oral glucose tolerance and reduced&#xD;
      nocturnal blood pressure dipping.&#xD;
&#xD;
      A secondary hypothesis of the study is that adrenal insufficiency patients on a replacement&#xD;
      regimen (as part of their standard of care ongoing treatment) that results in daytime&#xD;
      cortisol profiles approximating the normal diurnal variation will have better&#xD;
      cardio-metabolic function than adrenal insufficiency patients who have grossly abnormal&#xD;
      cortisol profiles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>day to day variability of sleep timing over 1 week of recording</measure>
    <time_frame>day 1 to day 7</time_frame>
    <description>On each day, the midpoint (time in hours and minutes) of the sleep period will be calculated and the variability over 1 week will be quantified by the standard deviation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>nocturnal blood pressure dipping</measure>
    <time_frame>day 8 to 9</time_frame>
    <description>a 24-h recording of blood pressure will be conducted in the laboratory with concurrent sleep recording. Dipping will be calculated as the difference between the daytime mean and the nighttime mean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oral glucose tolerance</measure>
    <time_frame>day 11 to 12</time_frame>
    <description>A 3-h 75g oral glucose tolerance test will be performed in the laboratory after an overnight fast. Glucose tolerance will be quantified by the total area under the glucose curve over the 3-hour period of sampling.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">86</enrollment>
  <condition>Adrenal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Healthy Controls</arm_group_label>
    <description>Matched by age, race, gender and BMI to adrenal insufficiency subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adrenal Insufficiency Patients</arm_group_label>
    <description>Eligible patients will have either primary adrenal insufficiency or secondary adrenal insufficiency and will be age 18 and older.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with primary or secondary Adrenal Insufficiency age 18 and older and healthy&#xD;
        matched control subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary or secondary adrenal insufficiency, Healthy matched controls, acute or&#xD;
             unstable health conditions age 18 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes, Tertiary adrenal insufficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eve Van Cauter, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenal Insufficiency</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/NCT03000231
org study id: 14-1484
nct id: NCT03000231
lead sponsor: 
has dmc: No
The purpose of this study is to compare cardio-metabolic risk, glucose tolerance, and night
      time blood pressure between healthy control subjects and patients with adrenal insufficiency.
      No intervention will be administered and the study is observational only.
We propose to use a case control design to test the main hypothesis that as compared to
      healthy control subjects matched for sex, age, adiposity and race/ethnicity, patients with
      adrenal insufficiency, whether primary or secondary, have disturbances of the circadian
      system that are associated with high day to day variability of sleep time as well as elevated
      markers of cardio-metabolic risk, including abnormal oral glucose tolerance and reduced
      nocturnal blood pressure dipping.

      A secondary hypothesis of the study is that adrenal insufficiency patients on a replacement
      regimen (as part of their standard of care ongoing treatment) that results in daytime
      cortisol profiles approximating the normal diurnal variation will have better
      cardio-metabolic function than adrenal insufficiency patients who have grossly abnormal
      cortisol profiles.
observational model: Case-Control
time perspective: Prospective
measure: day to day variability of sleep timing over 1 week of recording
time frame: day 1 to day 7
description: On each day, the midpoint (time in hours and minutes) of the sleep period will be calculated and the variability over 1 week will be quantified by the standard deviation
measure: nocturnal blood pressure dipping
time frame: day 8 to 9
description: a 24-h recording of blood pressure will be conducted in the laboratory with concurrent sleep recording. Dipping will be calculated as the difference between the daytime mean and the nighttime mean
measure: oral glucose tolerance
time frame: day 11 to 12
description: A 3-h 75g oral glucose tolerance test will be performed in the laboratory after an overnight fast. Glucose tolerance will be quantified by the total area under the glucose curve over the 3-hour period of sampling.
arm group label: Healthy Controls
description: Matched by age, race, gender and BMI to adrenal insufficiency subjects
arm group label: Adrenal Insufficiency Patients
description: Eligible patients will have either primary adrenal insufficiency or secondary adrenal insufficiency and will be age 18 and older.
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eve Van Cauter, Ph.D.
role: Principal Investigator
affiliation: University of Chicago
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adrenal Insufficiency
sharing ipd: No