<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/NCT03277911</url>
  </required_header>
  <id_info>
    <org_study_id>Clincal Pathology</org_study_id>
    <nct_id>NCT03277911</nct_id>
  </id_info>
  <brief_title>Thyroid Dysfunction and Dyslipidemia in Patients With Chronic Kidney Diseases</brief_title>
  <official_title>Thyroid Dysfunction and Dyslipidemia in Patients With Chronic Kidney Diseases</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Early diagnosis of thyroid and lipid disorders by regular screening, and treatment of such&#xD;
      disorders in CKD patients may be highly beneficial to slow progression of CKD. The study will&#xD;
      be conducted to investigate thyroid function and lipid profile in patients with chronic&#xD;
      kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic kidney disease[CKD] is becoming a serious health problem.The number of people with&#xD;
      impaired renal function is rapidly rising, especially in industrialized countries. It is&#xD;
      increasing rapidly worldwide at an annual growth rate of 8%. Chronic kidney disease [CKD] is&#xD;
      defined as kidney disease that has been present for months to years. Chronic kidney disease&#xD;
      [CKD] is a complex disease impacting more than twenty million individuals. Progression of CKD&#xD;
      is associated with a number of serious complications, including increased incidence of&#xD;
      cardiovascular disease, hyperlipidemia, anemia and metabolic bone disease .CKD patients&#xD;
      should be assessed for the presence of these complications and receive optimal treatment to&#xD;
      reduce their morbidity and mortality .&#xD;
&#xD;
      CKD affects thyroid function in many ways, including low thyroid circulating hormone levels,&#xD;
      altered peripheral hormone metabolism, insufficient binding to carrier proteins, reduced&#xD;
      tissue thyroid hormone content and altered iodine storage in the thyroid&#xD;
      gland.Thus,inCKD,thyroid hormone metabolism is impaired. . Hypothyroidism in patients with&#xD;
      renal failure causes many metabolic and clinical problems, and both these diseases can&#xD;
      mutually exacerbate their disturbances.. Chronic kidney disease has been known to affect&#xD;
      thyroid hormones metabolism .Low serum level of T3 and T4 are most remarkable laboratorial&#xD;
      finding. A high incidence of goiter and nodules on thyroid ultrasonography has been reported&#xD;
      in patients with end stage renal failure[ESRF]. CKD is often associated with dyslipidemia.&#xD;
      Several factors contribute to these changes. Patient with CKD have a reduction in the&#xD;
      activity of lipoprotein lipase and hepatic triglyceride lipase. This interferes with uptake&#xD;
      of triglyceride rich Apo lipoprotein B containing lipoprotein by the liver and in peripheral&#xD;
      tissue, yielding increased circulation of these atherogenic lipoproteins. Early diagnosis of&#xD;
      thyroid and lipid disorders by regular screening, and treatment of such disorders in CKD&#xD;
      patients may be highly beneficial to slow progression of CKD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 10, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2018</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>The study will be conducted to investigate thyroid function in patients with chronic kidney disease</measure>
    <time_frame>one year</time_frame>
    <description>serum urea, creatinine, , triiodothyronine [T3], free thyroxin [T4], thyroid stimulating hormones [TSH]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The study will be conducted to investigate lipid profile in patients with chronic kidney disease</measure>
    <time_frame>one year</time_frame>
    <description>serum urea, creatinine,high density lipoprotein [HDL] cholesterol, low density cholesterol, total cholesterol, triglyceride</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>CKD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be conducted on 80 patients with chronic kidney disease at Assuit University&#xD;
        hospital to investigate thyroid function and lipid profile in patients with CKD of stages&#xD;
        (1-5) and 20 subjects as a normal control. A total of newly diagnosed and known CKD cases&#xD;
        of stage 1-5 will be included in the study.&#xD;
&#xD;
        Sample Size Calculation:&#xD;
&#xD;
          -  Group I: Controls-20 age and sex matched normal individuals.&#xD;
&#xD;
          -  Group II: Cases -40 patients with stage 1-3.&#xD;
&#xD;
          -  Group III: Cases -40 patients with stage 4 and 5&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Patients with CKD stage (1-5).&#xD;
&#xD;
          2. Not known thyroid disorders.&#xD;
&#xD;
          3. Not in lipid lowering agents.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with known thyroid disorders, on medication affecting thyroid function and&#xD;
             lipid lowering agents are excluded from the study.&#xD;
&#xD;
          2. CKD patients who were or underwent previous dialysis.&#xD;
&#xD;
          3. Nephrotic syndrome.&#xD;
&#xD;
          4. Obesity.&#xD;
&#xD;
          5. Patients on estrogens, corticosteroids, antithyroid drugs, dietary supplements.&#xD;
&#xD;
          6. Pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sara Elewa Ahmed</investigator_full_name>
    <investigator_title>Resident of clinical pathology department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Dyslipidemias</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/NCT03277911
org study id: Clincal Pathology
nct id: NCT03277911
lead sponsor: 
has dmc: Yes
Early diagnosis of thyroid and lipid disorders by regular screening, and treatment of such
      disorders in CKD patients may be highly beneficial to slow progression of CKD. The study will
      be conducted to investigate thyroid function and lipid profile in patients with chronic
      kidney disease.
Chronic kidney disease[CKD] is becoming a serious health problem.The number of people with
      impaired renal function is rapidly rising, especially in industrialized countries. It is
      increasing rapidly worldwide at an annual growth rate of 8%. Chronic kidney disease [CKD] is
      defined as kidney disease that has been present for months to years. Chronic kidney disease
      [CKD] is a complex disease impacting more than twenty million individuals. Progression of CKD
      is associated with a number of serious complications, including increased incidence of
      cardiovascular disease, hyperlipidemia, anemia and metabolic bone disease .CKD patients
      should be assessed for the presence of these complications and receive optimal treatment to
      reduce their morbidity and mortality .

      CKD affects thyroid function in many ways, including low thyroid circulating hormone levels,
      altered peripheral hormone metabolism, insufficient binding to carrier proteins, reduced
      tissue thyroid hormone content and altered iodine storage in the thyroid
      gland.Thus,inCKD,thyroid hormone metabolism is impaired. . Hypothyroidism in patients with
      renal failure causes many metabolic and clinical problems, and both these diseases can
      mutually exacerbate their disturbances.. Chronic kidney disease has been known to affect
      thyroid hormones metabolism .Low serum level of T3 and T4 are most remarkable laboratorial
      finding. A high incidence of goiter and nodules on thyroid ultrasonography has been reported
      in patients with end stage renal failure[ESRF]. CKD is often associated with dyslipidemia.
      Several factors contribute to these changes. Patient with CKD have a reduction in the
      activity of lipoprotein lipase and hepatic triglyceride lipase. This interferes with uptake
      of triglyceride rich Apo lipoprotein B containing lipoprotein by the liver and in peripheral
      tissue, yielding increased circulation of these atherogenic lipoproteins. Early diagnosis of
      thyroid and lipid disorders by regular screening, and treatment of such disorders in CKD
      patients may be highly beneficial to slow progression of CKD.
observational model: Case-Control
time perspective: Cross-Sectional
measure: The study will be conducted to investigate thyroid function in patients with chronic kidney disease
time frame: one year
description: serum urea, creatinine, , triiodothyronine [T3], free thyroxin [T4], thyroid stimulating hormones [TSH]
measure: The study will be conducted to investigate lipid profile in patients with chronic kidney disease
time frame: one year
description: serum urea, creatinine,high density lipoprotein [HDL] cholesterol, low density cholesterol, total cholesterol, triglyceride
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sara Elewa Ahmed
investigator title: Resident of clinical pathology department
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Dyslipidemias