<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/NCT03018600</url>
  </required_header>
  <id_info>
    <org_study_id>PekingUMCH-ZS965</org_study_id>
    <nct_id>NCT03018600</nct_id>
  </id_info>
  <brief_title>Continuous Glucose Monitoring on Patients With Active Autoimmune Diseases Following High-dose Predisone Treatment</brief_title>
  <acronym>CGM</acronym>
  <official_title>Glucose Profiles of High-Dose Glucocorticoid Treatment in Young Patients With Diverse Autoimmune Disease With or Without Long-Term Low-Dose Glucocorticoid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Glucocorticoid is widely used in clinical treatment. Recently, there was research about&#xD;
      glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active&#xD;
      autoimmune diseases. Through this prospective trial, the investigators wanted to know the&#xD;
      blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone or&#xD;
      equivalent) in young patients (30-40 years) with active autoimmune diseases with or without&#xD;
      low-dose glucocorticoid maintenance. The investigators used continuous glucose monitoring for&#xD;
      72 hours to get a better understanding of the glucose levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As known to all, the dosage and duration of glucocorticoid influences the glucose levels in&#xD;
      different diseases. Continuous glucose monitoring becomes a newly effective technology to&#xD;
      better understand the glucose level. In this study,the investigators enrolled 25 patients&#xD;
      with certain active autoimmune diseases during high-dosage glucocorticoid therapy at Peking&#xD;
      Union Medical College Hospital. It was done by monitoring three-day continuous glucose levels&#xD;
      by holding continuous glucose monitoring system underneath the skin, which helped to show a&#xD;
      unique picture of fluctuations. The participants were divided into two groups according to&#xD;
      the glucocorticoid therapy. Group 1 enrolled subjects who were newly commenced 1-2mg/kg/day&#xD;
      prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for at least&#xD;
      five days. Group 2 enrolled subjects who had underwent less than 15mg/day&#xD;
      prednisone-equivalent glucocorticoid maintenance for at least 3 months but treated with&#xD;
      high-dose glucocorticoid for the relapse during the study This finding is useful for the&#xD;
      suitable treatment to control the hyperglycemia in young patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>glucose values of 24 hours (mmol/L);</measure>
    <time_frame>72 hours CGMS monitoring</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>the amounts of patients developing hyperglycemia</measure>
    <time_frame>72 hours CGMS monitoring</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Glucocorticoid-induced Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>We included 15 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) to the patients every morning at 8am for at least five days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>We included 10 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: using less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months and now treating with 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for the relapse of primary autoimmune disease for at least five days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>diet and exercise intervention</intervention_name>
    <description>consult nutrious doctors giving specific food and take regular exercise when under steroid therapy</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The participants tested the patients' blood sample for insulin, C peptide, HbA1c, GA and&#xD;
      other basic biochemical values (liver and renal function, lipid levels).&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects were recruited from inpatients admitted to the Immunology Department, Peking&#xD;
        Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1,&#xD;
        2016. Patients' primary disease was diagnosed according to the criteria by American College&#xD;
        of Rheumatology. The spectrum of autoimmune disease included Systemic lupus Erythematosus&#xD;
        (SLE), Connective tissue disorders, Sjogren Syndrome, Systemic sclerosis, IgG4-related&#xD;
        disease, Bahcet's disease, ANCA-associated vasculitis, polymyositis, dermatomyositis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Young patients with exacerbation of autoimmune disease, requiring 1-2mg/kg/day&#xD;
             prednisone or equivalent for treatment;&#xD;
&#xD;
          -  could undergo &lt;15mg/kg/day prednisone or equivalent glucocorticoid maintenance in the&#xD;
             previous three months;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with history of diabetes;&#xD;
&#xD;
          -  patients with severe organ dysfunction or failure;&#xD;
&#xD;
          -  patients with febrile conditions;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>January 7, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prednisone, autoimmune disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
    <mesh_term>Autoimmune Diseases</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/NCT03018600
org study id: PekingUMCH-ZS965
nct id: NCT03018600
lead sponsor: 
has dmc: Yes
Glucocorticoid is widely used in clinical treatment. Recently, there was research about
      glucose fluctuations under low-dose and pulse steroid therapy in elderly patients with active
      autoimmune diseases. Through this prospective trial, the investigators wanted to know the
      blood glucose characteristics under high dosage glucocorticoid (1-2 mg/kg/day prednisone or
      equivalent) in young patients (30-40 years) with active autoimmune diseases with or without
      low-dose glucocorticoid maintenance. The investigators used continuous glucose monitoring for
      72 hours to get a better understanding of the glucose levels.
As known to all, the dosage and duration of glucocorticoid influences the glucose levels in
      different diseases. Continuous glucose monitoring becomes a newly effective technology to
      better understand the glucose level. In this study,the investigators enrolled 25 patients
      with certain active autoimmune diseases during high-dosage glucocorticoid therapy at Peking
      Union Medical College Hospital. It was done by monitoring three-day continuous glucose levels
      by holding continuous glucose monitoring system underneath the skin, which helped to show a
      unique picture of fluctuations. The participants were divided into two groups according to
      the glucocorticoid therapy. Group 1 enrolled subjects who were newly commenced 1-2mg/kg/day
      prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for at least
      five days. Group 2 enrolled subjects who had underwent less than 15mg/day
      prednisone-equivalent glucocorticoid maintenance for at least 3 months but treated with
      high-dose glucocorticoid for the relapse during the study This finding is useful for the
      suitable treatment to control the hyperglycemia in young patients.
observational model: Cohort
time perspective: Prospective
measure: glucose values of 24 hours (mmol/L);
time frame: 72 hours CGMS monitoring
measure: the amounts of patients developing hyperglycemia
time frame: 72 hours CGMS monitoring
arm group label: 1
description: We included 15 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) to the patients every morning at 8am for at least five days.
arm group label: 2
description: We included 10 inpatients admitted to the Immunology Department, Peking Union Medical College Hospital (PUMCH), Beijing, China from April 1, 2016 to September 1, 2016.Intervention including glucocorticoid: using less than 15mg/day prednisone-equivalent glucocorticoid maintenance for at least 3 months and now treating with 1-2mg/kg/day prednisone-equivalent (intravenous/oral methylpredisolone or oral prednisone) for the relapse of primary autoimmune disease for at least five days.
intervention type: Behavioral
intervention name: diet and exercise intervention
description: consult nutrious doctors giving specific food and take regular exercise when under steroid therapy
arm group label: 1
arm group label: 2
The participants tested the patients' blood sample for insulin, C peptide, HbA1c, GA and
      other basic biochemical values (liver and renal function, lipid levels).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 46 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Hyperglycemia
mesh term: Autoimmune Diseases
sharing ipd: No