<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/NCT03257566</url>
  </required_header>
  <id_info>
    <org_study_id>rfihtptd</org_study_id>
    <nct_id>NCT03257566</nct_id>
  </id_info>
  <brief_title>Hypothyroidism in Patients With Type 1 Diabetes</brief_title>
  <official_title>Risk Factors of Incidence of Hypothyroidism in Patients With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Therefore, for early detection of hypothyroidism in children with type 1 diabetes, it is&#xD;
      suggested to measure anti-thyroid antibodies and thyroid stimulating hormone at disease onset&#xD;
      and in yearly intervals after the age of 12 yr. Furthermore, the International Society for&#xD;
      Pediatric and Adolescent Diabetes Consensus Clinical Guidelines recommend the screening of&#xD;
      thyroid function by analysing circulating thyroid stimulating hormone at the diagnosis of&#xD;
      diabetes and, thereafter every 2nd yr. in asymptomatic individuals without goitre and more&#xD;
      frequent if goitre present .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 1 diabetes is an organ-specific autoimmune disease characterized by the selective&#xD;
      destruction of pancreatic β-cells. The histopathology of type 1 diabetes is defined by a&#xD;
      decreased β-cell mass infiltration of mononuclear cells into the islets of Langerhans , this&#xD;
      lesion was later called 'insulitis', and it is the hallmark of the disease .&#xD;
&#xD;
      Insulitis was observed in 70% of patients with acute onset type 1 diabetes and concluded that&#xD;
      this disease was caused by a β-cell-specific autoimmune process .&#xD;
&#xD;
      Furthermore, in a study demonstrated cellular autoimmunity in patients with type 1 diabetes&#xD;
      using the leukocyte migration test and speculated that cellular hypersensitivity was the&#xD;
      counter part of lymphocytic infiltration in islets . Therefore, it is speculated that&#xD;
      cell-mediated immunity could play an important part in the pathogenesis of type 1 diabetes .&#xD;
&#xD;
      As a view suggesting that type 1 diabetes is an autoimmune disease, there is some evidence&#xD;
      that type 1 diabetes is often complicated with other autoimmune diseases or that anti-islet&#xD;
      antibodies precede the clinical onset of the disease.&#xD;
&#xD;
      So, it is found that type 1 diabetes is frequently associated with other organ-specific&#xD;
      autoimmune diseases, including hypothyroidism , pernicious anaemia, and idiopathic Addison's&#xD;
      disease .The most common coexisting organ autoimmune disease is hypothyroidism (&gt;90%), the&#xD;
      prevalence of anti-thyroid autoantibodies in children with type 1 diabetes at disease onset&#xD;
      is about 20% .&#xD;
&#xD;
      It is generally accepted that is a T cell-mediated autoimmune disease and that circulating&#xD;
      autoantibodies to various islet cell antigens are induced following the destruction of&#xD;
      pancreatic β cells .&#xD;
&#xD;
      Furthermore, it is reported that the prevalence of anti-thyroid antibodies increases with&#xD;
      increasing age and that the presence of anti-thyroid antibodies at diagnosis of type 1&#xD;
      diabetes predicts the development of future thyroid disease as patients with antithyroid&#xD;
      antibodies are 18 times more likely to develop thyroid disease than patients without&#xD;
      anti-thyroid antibodies .&#xD;
&#xD;
      Therefore, for early detection of hypothyroidism in children with type 1 diabetes, it is&#xD;
      suggested to measure anti-thyroid antibodies and thyroid stimulating hormone at disease onset&#xD;
      and in yearly intervals after the age of 12 yr. Furthermore, the International Society for&#xD;
      Pediatric and Adolescent Diabetes Consensus Clinical Guidelines recommend the screening of&#xD;
      thyroid function by analysing circulating thyroid stimulating hormone at the diagnosis of&#xD;
      diabetes and, thereafter every 2nd yr. in asymptomatic individuals without goitre and more&#xD;
      frequent if goitre present .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Screening the incidence of hypothyroidism in patients with type 1 diabetes</measure>
    <time_frame>after 1-2 years after diagnosis of Diabetes</time_frame>
    <description>Measuring of thyroid stimulating hormone in patients with type 1 diabetes</description>
  </primary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Hypothyroidism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be applied on children with type 1 diabetes attending Diabetes Clinic at&#xD;
        Sidy Galal Health Assurance Clinic in Assuit , aging between 8 - 15 yrs .&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Children with type 1 diabetes aging between 8 - 15 y .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cases with hyperthyroidism .&#xD;
&#xD;
          2. Areas known to have endemic goitre due to nutritional iodine deficiency .&#xD;
&#xD;
          3. History of maternal hypothyroidism and / or congenital hypothyroidism .&#xD;
&#xD;
          4. Children known to be normoglycaemic with already presented thyroid dysfunction .&#xD;
&#xD;
          5. Children with multiple endocrinopathies .&#xD;
&#xD;
          6. Children under treatment with drugs inducing hypothyroidism like amiodarone , lithium&#xD;
             .&#xD;
&#xD;
          7. Children under treatment with drugs affecting insulin secretion like steroids , growth&#xD;
             hormone therapy .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Farouk Hassanen, MD</last_name>
    <phone>+201006178123</phone>
    <email>Dr.amir63@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohamed Amir, MD</last_name>
    <phone>+201005689353</phone>
    <email>Dr.amir63@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Romany Safwat</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothyroidism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03257566
org study id: rfihtptd
nct id: NCT03257566
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Therefore, for early detection of hypothyroidism in children with type 1 diabetes, it is
      suggested to measure anti-thyroid antibodies and thyroid stimulating hormone at disease onset
      and in yearly intervals after the age of 12 yr. Furthermore, the International Society for
      Pediatric and Adolescent Diabetes Consensus Clinical Guidelines recommend the screening of
      thyroid function by analysing circulating thyroid stimulating hormone at the diagnosis of
      diabetes and, thereafter every 2nd yr. in asymptomatic individuals without goitre and more
      frequent if goitre present .
Type 1 diabetes is an organ-specific autoimmune disease characterized by the selective
      destruction of pancreatic β-cells. The histopathology of type 1 diabetes is defined by a
      decreased β-cell mass infiltration of mononuclear cells into the islets of Langerhans , this
      lesion was later called 'insulitis', and it is the hallmark of the disease .

      Insulitis was observed in 70% of patients with acute onset type 1 diabetes and concluded that
      this disease was caused by a β-cell-specific autoimmune process .

      Furthermore, in a study demonstrated cellular autoimmunity in patients with type 1 diabetes
      using the leukocyte migration test and speculated that cellular hypersensitivity was the
      counter part of lymphocytic infiltration in islets . Therefore, it is speculated that
      cell-mediated immunity could play an important part in the pathogenesis of type 1 diabetes .

      As a view suggesting that type 1 diabetes is an autoimmune disease, there is some evidence
      that type 1 diabetes is often complicated with other autoimmune diseases or that anti-islet
      antibodies precede the clinical onset of the disease.

      So, it is found that type 1 diabetes is frequently associated with other organ-specific
      autoimmune diseases, including hypothyroidism , pernicious anaemia, and idiopathic Addison's
      disease .The most common coexisting organ autoimmune disease is hypothyroidism (>90%), the
      prevalence of anti-thyroid autoantibodies in children with type 1 diabetes at disease onset
      is about 20% .

      It is generally accepted that is a T cell-mediated autoimmune disease and that circulating
      autoantibodies to various islet cell antigens are induced following the destruction of
      pancreatic β cells .

      Furthermore, it is reported that the prevalence of anti-thyroid antibodies increases with
      increasing age and that the presence of anti-thyroid antibodies at diagnosis of type 1
      diabetes predicts the development of future thyroid disease as patients with antithyroid
      antibodies are 18 times more likely to develop thyroid disease than patients without
      anti-thyroid antibodies .

      Therefore, for early detection of hypothyroidism in children with type 1 diabetes, it is
      suggested to measure anti-thyroid antibodies and thyroid stimulating hormone at disease onset
      and in yearly intervals after the age of 12 yr. Furthermore, the International Society for
      Pediatric and Adolescent Diabetes Consensus Clinical Guidelines recommend the screening of
      thyroid function by analysing circulating thyroid stimulating hormone at the diagnosis of
      diabetes and, thereafter every 2nd yr. in asymptomatic individuals without goitre and more
      frequent if goitre present .
observational model: Case-Control
time perspective: Cross-Sectional
measure: Screening the incidence of hypothyroidism in patients with type 1 diabetes
time frame: after 1-2 years after diagnosis of Diabetes
description: Measuring of thyroid stimulating hormone in patients with type 1 diabetes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Farouk Hassanen, MD
phone: +201006178123
email: Dr.amir63@yahoo.com
last name: Mohamed Amir, MD
phone: +201005689353
email: Dr.amir63@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Romany Safwat
investigator title: principal investigator
mesh term: Hypothyroidism
sharing ipd: Undecided