<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/NCT03001336</url>
  </required_header>
  <id_info>
    <org_study_id>DIA-THY-1</org_study_id>
    <nct_id>NCT03001336</nct_id>
  </id_info>
  <brief_title>Thyroid Function and Diabetes Complications</brief_title>
  <official_title>Association Between Thyroid Function and Diabetes Complications in Elderly Patients With Type 2 Diabetes Mellitus in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing First Hospital, Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the potential association between thyroid&#xD;
      function and diabetes complications in the elderly subjects with type 2 diabetes mellitus&#xD;
      (T2DM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims: We investigated the potential association between thyroid parameters and&#xD;
      microalbuminuria in the euthyroid elderly subjects with type 2 diabetes mellitus (T2DM).&#xD;
&#xD;
      Subjects: Elderly inhospital patients with T2DM who visited in the Department of&#xD;
      Endocrinology at the Nanjing First Hospital from January 2011 to December 2012.&#xD;
&#xD;
      Methods: Clinical factors, serum levels of glucose, lipids, free triiodothyronine (FT3), free&#xD;
      thyroxine (FT4), thyroid-stimulating hormone (TSH), thyroid autoantibodies,24h urine&#xD;
      albuminuria and fluorescence fundus angiography are conducted.&#xD;
&#xD;
      The relationships levels of thyroid function and diabetic complications are analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diabetic retinopathy which is diagnosed by the measurement of fundus fluorescein angiography. (Diabetic retinopathy is clinically graded based on the international clinical diabetic retinopathy severity scales.)</measure>
    <time_frame>Day One</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>24h-albuminuria</measure>
    <time_frame>Day One</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">260</enrollment>
  <condition>Diabetes</condition>
  <condition>Thyroid Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>This is a cross-sectional study</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing&#xD;
        First Hospital from January 2011 to December 2012 were enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients are ≥ 60 years old, with T2DM and the diagnostic criteria of T2DM is&#xD;
             according to the World Health Organization in 1999.&#xD;
&#xD;
          2. Patients have normal thyroid function and negative for thyroid autoantibodies, such as&#xD;
             thyroid peroxidase antibody (TPOAb) or thyroglobulin antibody (TGAb).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of thyroid disease or chronic liver disease or nondiabetic&#xD;
             renal problems or cancer.&#xD;
&#xD;
          2. Patients use systemic drug therapy such as thyroxine, anti-thyroid drugs,&#xD;
             glucocorticoids and oral contraceptives.&#xD;
&#xD;
          3. Patients are pregnant or lactating women.&#xD;
&#xD;
          4. Patients with acute intercurrent illness of diabetes.&#xD;
&#xD;
          5. Patients with an acute infection.&#xD;
&#xD;
          6. Patients with a history of drug abuse alcohol dependence in the past 5 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2011</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thyroid</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
    <mesh_term>Diabetes Complications</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/NCT03001336
org study id: DIA-THY-1
nct id: NCT03001336
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the potential association between thyroid
      function and diabetes complications in the elderly subjects with type 2 diabetes mellitus
      (T2DM).
Aims: We investigated the potential association between thyroid parameters and
      microalbuminuria in the euthyroid elderly subjects with type 2 diabetes mellitus (T2DM).

      Subjects: Elderly inhospital patients with T2DM who visited in the Department of
      Endocrinology at the Nanjing First Hospital from January 2011 to December 2012.

      Methods: Clinical factors, serum levels of glucose, lipids, free triiodothyronine (FT3), free
      thyroxine (FT4), thyroid-stimulating hormone (TSH), thyroid autoantibodies,24h urine
      albuminuria and fluorescence fundus angiography are conducted.

      The relationships levels of thyroid function and diabetic complications are analysed.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Diabetic retinopathy which is diagnosed by the measurement of fundus fluorescein angiography. (Diabetic retinopathy is clinically graded based on the international clinical diabetic retinopathy severity scales.)
time frame: Day One
measure: 24h-albuminuria
time frame: Day One
intervention type: Other
intervention name: no intervention
description: This is a cross-sectional study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Thyroid Diseases
mesh term: Diabetes Complications
sharing ipd: No