<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/NCT02220257</url>
  </required_header>
  <id_info>
    <org_study_id>REMISSIONDM1</org_study_id>
    <nct_id>NCT02220257</nct_id>
  </id_info>
  <brief_title>The Influence of Partial Remission Phase of Type 1 Diabetes on Patient Outcome</brief_title>
  <acronym>POZREM</acronym>
  <official_title>Influence of Occurrence of Remission and Its Duration on Development of Chronic Complications of Type 1 Diabetes and Patient Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poznan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poznan University of Medical Sciences</source>
  <brief_summary>
    <textblock>
      Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets&#xD;
      of Langerhans in the pancreas. Symptoms of diabetes present when the mass of&#xD;
      insulin-producing cells reaches a point where insulin concentration does not suffice to&#xD;
      maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of&#xD;
      diabetes and initiation of insulin therapy. This phenomenon is called a remission.&#xD;
&#xD;
      The aim of this study is to asses the influence of occurrence and duration of remission on&#xD;
      development of chronic complications of diabetes and patients outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets&#xD;
      of Langerhans in the pancreas. Symptoms of diabetes present when the mass of&#xD;
      insulin-producing cells reaches a point where insulin concentration does not suffice to&#xD;
      maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of&#xD;
      diabetes and initiation of insulin therapy. This phenomenon is called a remission.&#xD;
&#xD;
      The aim of this study is to asses influence of occurrence and duration of remission on&#xD;
      development of chronic complications of diabetes and patients outcome.&#xD;
&#xD;
      Clinical remission was defined as time in which all of the following criteria were met: HbA1c&#xD;
      below 6.5 % , dose of exogenous insulin below 0.3 U / kg body weight and serum C-peptide&#xD;
      concentration above 0.5 ng / ml. Patients were divided into those who were in remission at&#xD;
      any time during follow-up (remitters) and non-remitters.&#xD;
&#xD;
      At follow-up occurrence of chronic microvascular complications of diabetes (retinopathy,&#xD;
      diabetic kidney disease and neuropathy) was evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy)</measure>
    <time_frame>Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Diabetes Mellitus Type 1</condition>
  <condition>Remission of Type 1 Diabetes</condition>
  <condition>Chronic Complications of Diabetes</condition>
  <arm_group>
    <arm_group_label>Newly diagnosed type 1 diabetes</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study included 240 consecutive patients, including 77 women and 143 men hospitalized at&#xD;
        the Department of Internal Medicine and Diabetology of Poznan University of Medical&#xD;
        Sciences between 2004 and 2007 due to newly diagnosed type 1 diabetes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Newly diagnosed type 1 diabetes according to ADA (American Diabetes Association) 1997&#xD;
             criteria.&#xD;
&#xD;
          2. Age 18-35 years&#xD;
&#xD;
          3. Education with regard to intensive functional insulin therapy at the time of diagnosis&#xD;
&#xD;
          4. Patient consent to participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute inflammation (serum C-reactive protein concentration (hsCRP) &gt;10mg/L,&#xD;
             leukocytosis &gt;15x109/L, erythrocyte sedimentation rate (OB) &gt;30 mm/h)&#xD;
&#xD;
          2. Laboratory signs of liver damage: alanine and aspartate aminotransferase elevated&#xD;
             2-fold over the upper limit of normal range&#xD;
&#xD;
          3. History of other chronic diseases (e.g. asthma, neoplastic diseases, liver cirrhosis)&#xD;
&#xD;
          4. Other autoimmunological diseases other than diabetes&#xD;
&#xD;
          5. Not confirming type 1 diabetes after obtaining results of autoantibodies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paweł Niedźwiecki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Poznan University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Franciszek Raszeja Hospital; Poznan University of Medical Science</name>
      <address>
        <city>Poznań</city>
        <state>Greater Poland</state>
        <zip>60-834</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Poznan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Paweł Niedźwiecki</investigator_full_name>
    <investigator_title>MD Paweł Niedźwiecki</investigator_title>
  </responsible_party>
  <keyword>diabetes mellitus type 1</keyword>
  <keyword>remission, honeymoon</keyword>
  <keyword>microangiopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_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/NCT02220257
org study id: REMISSIONDM1
nct id: NCT02220257
lead sponsor: 
Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets
      of Langerhans in the pancreas. Symptoms of diabetes present when the mass of
      insulin-producing cells reaches a point where insulin concentration does not suffice to
      maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of
      diabetes and initiation of insulin therapy. This phenomenon is called a remission.

      The aim of this study is to asses the influence of occurrence and duration of remission on
      development of chronic complications of diabetes and patients outcome.
Natural course of diabetes mellitus involves gradual reduction of β cell mass within islets
      of Langerhans in the pancreas. Symptoms of diabetes present when the mass of
      insulin-producing cells reaches a point where insulin concentration does not suffice to
      maintain proper glycaemia. In many patients β cells regenerate shortly after the diagnosis of
      diabetes and initiation of insulin therapy. This phenomenon is called a remission.

      The aim of this study is to asses influence of occurrence and duration of remission on
      development of chronic complications of diabetes and patients outcome.

      Clinical remission was defined as time in which all of the following criteria were met: HbA1c
      below 6.5 % , dose of exogenous insulin below 0.3 U / kg body weight and serum C-peptide
      concentration above 0.5 ng / ml. Patients were divided into those who were in remission at
      any time during follow-up (remitters) and non-remitters.

      At follow-up occurrence of chronic microvascular complications of diabetes (retinopathy,
      diabetic kidney disease and neuropathy) was evaluated.
observational model: Case-Only
time perspective: Prospective
measure: Development of chronic complication of diabetes (retinopathy or neuropathy or nephropathy)
time frame: Evaluation for chronic complications of diabetes was conducted after a period of no less than 5 years from diagnosis.
arm group label: Newly diagnosed type 1 diabetes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Paweł Niedźwiecki, MD
role: Principal Investigator
affiliation: Poznan University of Medical Sciences
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Poznan University of Medical Sciences
investigator full name: Paweł Niedźwiecki
investigator title: MD Paweł Niedźwiecki
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1