xml: <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/NCT06009250</url>
    </required_header>
    <id_info>
      <org_study_id>NAFLD and CKD</org_study_id>
      <nct_id>NCT06009250</nct_id>
    </id_info>
    <brief_title>Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut</brief_title>
    <official_title>Prevalence of Non-alcoholic Fatty Liver Disease in Patients With Chronic Kidney Disease in Assiut</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Muhammad Ameen Abdelrady Abdelaziz</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <brief_summary>
      <textblock>
        The goal of this observational study is to detect the prevalence of NAFLD in CKD patients&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  [question 1] prevalence of NAFLD in CKD patients.&#xD;
  &#xD;
          -  [question 2] the relationship between NAFLD and CKD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this observational study is to detect the prevalence of NAFLD in CKD patients&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  [question 1] prevalence of NAFLD in CKD patients.&#xD;
  &#xD;
          -  [question 2] the relationship between NAFLD and CKD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>abdominal ultrasound</measure>
      <time_frame>1 year</time_frame>
      <description>assessment of Liver regarding fatty liver disease by Ultrasound.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>liver enzymes</measure>
      <time_frame>1 year</time_frame>
      <description>participants will undergo assessment of liver enzymes (AST and ALT) and results will be reporeted in a table.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fibroscan</measure>
      <time_frame>1 year</time_frame>
      <description>participants will undergo fibroscanning of the liver to assess NAFLD and results will be reported in a table.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>BUN, Cr level and estimated GFR</measure>
      <time_frame>1 year</time_frame>
      <description>participants will be assessed regarding BUN, CR and estimated GFR to confirm and follow up CKD patients involved in the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lipid Profile</measure>
      <time_frame>1 year</time_frame>
      <description>participants will be assessed regarding Cholesterol level, Triglycerides, HDL and LDL. results will be reported in a table</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Complete Blood Picture (WBCs, HB, Patelets</measure>
      <time_frame>1 year</time_frame>
      <description>total leucocytic count Hemoglobin level and platelet count will be assessed in our patients and will be reported in a table</description>
    </primary_outcome>
    <primary_outcome>
      <measure>serum Uric Acid</measure>
      <time_frame>1 year</time_frame>
      <description>serum uric acid will be assessed and reported in our patients</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Waist Circumference</measure>
      <time_frame>1 year</time_frame>
      <description>waist circumference measurement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>1 year</time_frame>
      <description>BMI will also be calculated.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>CKD</condition>
    <condition>NAFLD</condition>
    <arm_group>
      <arm_group_label>CKD patients</arm_group_label>
      <description>CKD patient who are not DM are investigated for the presence of NAFLD</description>
    </arm_group>
    <arm_group>
      <arm_group_label>normal control group</arm_group_label>
      <description>normal population are investigated to know the prevalence of NAFLD in contrast to patients with CKD.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          CKD patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  CKD patients&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  HCV and HBV Positive patients&#xD;
  &#xD;
            -  Alcoholics&#xD;
  &#xD;
            -  patient on Hemodialysis&#xD;
  &#xD;
            -  patients with wilson disease&#xD;
  &#xD;
            -  patients with alpha one antitrypsin deficiency&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Muhammad Ameen Abdelrady Abdelaziz</investigator_full_name>
      <investigator_title>Internal Medicine Resident</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Liver Diseases</mesh_term>
      <mesh_term>Fatty Liver</mesh_term>
      <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06009250
  org study id: NAFLD and CKD
  nct id: NCT06009250
  lead sponsor: 
  The goal of this observational study is to detect the prevalence of NAFLD in CKD patients
  
        The main question[s] it aims to answer are:
  
          -  [question 1] prevalence of NAFLD in CKD patients.
  
          -  [question 2] the relationship between NAFLD and CKD.
  The goal of this observational study is to detect the prevalence of NAFLD in CKD patients
  
        The main question[s] it aims to answer are:
  
          -  [question 1] prevalence of NAFLD in CKD patients.
  
          -  [question 2] the relationship between NAFLD and CKD.
  observational model: Case-Control
  time perspective: Retrospective
  measure: abdominal ultrasound
  time frame: 1 year
  description: assessment of Liver regarding fatty liver disease by Ultrasound.
  measure: liver enzymes
  time frame: 1 year
  description: participants will undergo assessment of liver enzymes (AST and ALT) and results will be reporeted in a table.
  measure: Fibroscan
  time frame: 1 year
  description: participants will undergo fibroscanning of the liver to assess NAFLD and results will be reported in a table.
  measure: BUN, Cr level and estimated GFR
  time frame: 1 year
  description: participants will be assessed regarding BUN, CR and estimated GFR to confirm and follow up CKD patients involved in the study.
  measure: Lipid Profile
  time frame: 1 year
  description: participants will be assessed regarding Cholesterol level, Triglycerides, HDL and LDL. results will be reported in a table
  measure: Complete Blood Picture (WBCs, HB, Patelets
  time frame: 1 year
  description: total leucocytic count Hemoglobin level and platelet count will be assessed in our patients and will be reported in a table
  measure: serum Uric Acid
  time frame: 1 year
  description: serum uric acid will be assessed and reported in our patients
  measure: Waist Circumference
  time frame: 1 year
  description: waist circumference measurement.
  measure: Body Mass Index
  time frame: 1 year
  description: BMI will also be calculated.
  arm group label: CKD patients
  description: CKD patient who are not DM are investigated for the presence of NAFLD
  arm group label: normal control group
  description: normal population are investigated to know the prevalence of NAFLD in contrast to patients with CKD.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  responsible party type: Sponsor-Investigator
  investigator affiliation: Assiut University
  investigator full name: Muhammad Ameen Abdelrady Abdelaziz
  investigator title: Internal Medicine Resident
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic