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/NCT05974904</url>
    </required_header>
    <id_info>
      <org_study_id>ChongqingMUU</org_study_id>
      <nct_id>NCT05974904</nct_id>
    </id_info>
    <brief_title>Dose-response Association Between hsCAR and MAFLD: A Cross-sectional Study</brief_title>
    <official_title>Dose-response Association Between High-sensitivity C-reactive Protein to Albumin Ratio and Metabolic Dysfunction-associated Fatty Liver Disease: A Cross-sectional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chongqing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chongqing Medical University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to investigate the associations between a novel&#xD;
        inflammatory marker, high sensitivity C-reactiveprotein to albumin ratio (hsCAR), and&#xD;
        steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (MAFLD).&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
        [question 1] Can hsCAR serve as a clinical indicator to determine whether a patient has MAFD?&#xD;
        [question 2] Can hsCAR determine whether MAFLD patients are complicated with liver fibrosis?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background Inflammation is related to the occurrence and development of fatty liver. Our&#xD;
        research aimed to investigate the link between an inflammatory indicator, high-sensitivity&#xD;
        C-reactive protein to albumin ratio (hsCAR), and metabolic dysfunction-associated fatty liver&#xD;
        disease (MAFLD).&#xD;
  &#xD;
        Methods Ultrasonic indices were used to evaluate the severity of liver steatosis and fibrosis&#xD;
        of participants from the NHANES database, respectively. The relationship between hsCAR and&#xD;
        MAFLD was explored using multivariate logistic regression analysis, restricted cubic splines&#xD;
        (RCS) as well as threshold analysis. Finally, subgroup analyses were performed using the same&#xD;
        methodology.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">July 28, 2023</completion_date>
    <primary_completion_date type="Anticipated">July 28, 2023</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>Controlled attenuation parameter</measure>
      <time_frame>at baseline</time_frame>
      <description>Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Liver stiffness measurement</measure>
      <time_frame>at baseline</time_frame>
      <description>Liver stiffness measurement is an ultrasound indicator measured by FibroScan to evaluate the degree of liver stiffness</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">7000</enrollment>
    <condition>Metabolic Dysfunction-associated Fatty Liver Disease</condition>
    <condition>Hepatic Steatosis</condition>
    <condition>Liver Fibrosis</condition>
    <arm_group>
      <arm_group_label>Non-MAFLD group</arm_group_label>
      <description>controlled attenuation parameter&lt;274 dB/m</description>
    </arm_group>
    <arm_group>
      <arm_group_label>MAFLD group</arm_group_label>
      <description>controlled attenuation parameter ≥ 274 dB/m</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-fibrosis group</arm_group_label>
      <description>liver stiffness measurement &lt; 8.2 kPa</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fibrosis group</arm_group_label>
      <description>liver stiffness measurement ≥ 8.2 kPa</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>high-sensitivity C-reactive protein to albumin ratio</intervention_name>
      <description>High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.</description>
      <arm_group_label>Fibrosis group</arm_group_label>
      <arm_group_label>MAFLD group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          They all come from the National Health and Nutrition Examination Survey, which is a&#xD;
          database that contains information about demographics, dietary, examination, laboratory and&#xD;
          questionnaire of the American population obtained through sophisticated sampling&#xD;
          strategies.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Total participants from NHANES 2017-2020&#xD;
  &#xD;
            -  Participants diagnosed with MAFLD. Metabolic dysfunction-associated fatty liver&#xD;
               disease (MAFLD) is the term used to describe hepatic steatosis in the presence of&#xD;
               metabolic abnormalities, excess weight, obesity, or type 2 diabetic mellitus.&#xD;
  &#xD;
                 1. Diagnosis of diabetes mellitus: (1) taking glucose-lowering drugs; (2) HbA1c ≥&#xD;
                    6.5% (48 mmol/mol); (3) fasting plasma glucose ≥ 7.0 mmol/L (126 mg/dL); (4)&#xD;
                    2-hour plasma glucose (2hPG) ≥ 11.1 mmol/L (200 mg/dL).&#xD;
  &#xD;
                 2. Overweight or obesity: defined as BMI≥25 kg/m2 in Caucasians or BMI≥23 kg/m2 in&#xD;
                    Asians&#xD;
  &#xD;
                 3. If presence of at least two metabolic risk abnormalities:&#xD;
  &#xD;
                      -  Waist circumference≥102/88 cm in Caucasian men and women (or≥90/80 cm in&#xD;
                         Asian men and women)&#xD;
  &#xD;
                      -  Blood pressure≥130/85 mmHg or specific drug treatment&#xD;
  &#xD;
                      -  Plasma triglycerides≥150 mg/dl (≥1.70 mmol/L) or specific drug treatment&#xD;
  &#xD;
                      -  Plasma HDL-cholesterol &lt;40 mg/dl (&lt;1.0 mmol/L) for men and &lt;50 mg/dl (&lt;1.3&#xD;
                         mmol/L) for women or specific drug treatment&#xD;
  &#xD;
                      -  Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl [5.6 to 6.9&#xD;
                         mmol/L], or 2-hour post-load glucose levels 140 to 199 mg/dl [7.8 to 11.0&#xD;
                         mmol] or HbA1c 5.7% to 6.4% [39 to 47 mmol/mol])&#xD;
  &#xD;
                      -  Homeostasis model assessment of insulin resistance score≥2.5&#xD;
  &#xD;
                      -  Plasma high-sensitivity C-reactive protein level &gt;2 mg/L&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Liver ultrasound data not available&#xD;
  &#xD;
            -  participants without complete clinical data&#xD;
  &#xD;
            -  participants under 18 years old&#xD;
  &#xD;
            -  participants with cancer.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Tingqiu Wang, Bachelor</last_name>
      <role>Study Director</role>
      <affiliation>The Second Affiliated Hospital of Chongqing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tingqiu Wang, Bachelor</last_name>
      <phone>+8617815370539</phone>
      <email>w857683014@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhigang Luo, Master</last_name>
      <phone>+8618989126596</phone>
      <email>306395@hospital.cqmu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tingqiu Wang, Bachelor</last_name>
        <phone>17815370539</phone>
        <email>w857683014@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.</citation>
      <PMID>32278004</PMID>
    </reference>
    <reference>
      <citation>Eddowes PJ, Sasso M, Allison M, Tsochatzis E, Anstee QM, Sheridan D, Guha IN, Cobbold JF, Deeks JJ, Paradis V, Bedossa P, Newsome PN. Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 May;156(6):1717-1730. doi: 10.1053/j.gastro.2019.01.042. Epub 2019 Jan 25.</citation>
      <PMID>30689971</PMID>
    </reference>
    <reference>
      <citation>Karimi A, Shobeiri P, Kulasinghe A, Rezaei N. Novel Systemic Inflammation Markers to Predict COVID-19 Prognosis. Front Immunol. 2021 Oct 22;12:741061. doi: 10.3389/fimmu.2021.741061. eCollection 2021.</citation>
      <PMID>34745112</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chongqing Medical University</investigator_affiliation>
      <investigator_full_name>Tingqiu Wang</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>high-sensitivity C-reactive protein to albumin ratio</keyword>
    <keyword>metabolic dysfunction-associated fatty liver disease</keyword>
    <keyword>National Health and Nutrition Examination Survey</keyword>
    <keyword>control attenuation parameter</keyword>
    <keyword>liver stiffness measurement</keyword>
    <keyword>inflammation</keyword>
    <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>Liver Cirrhosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05974904
  org study id: ChongqingMUU
  nct id: NCT05974904
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to investigate the associations between a novel
        inflammatory marker, high sensitivity C-reactiveprotein to albumin ratio (hsCAR), and
        steatosis and fibrosis of metabolic dysfunction-associated fatty liver disease (MAFLD).
  
        The main question[s] it aims to answer are:
  
        [question 1] Can hsCAR serve as a clinical indicator to determine whether a patient has MAFD?
        [question 2] Can hsCAR determine whether MAFLD patients are complicated with liver fibrosis?
  Background Inflammation is related to the occurrence and development of fatty liver. Our
        research aimed to investigate the link between an inflammatory indicator, high-sensitivity
        C-reactive protein to albumin ratio (hsCAR), and metabolic dysfunction-associated fatty liver
        disease (MAFLD).
  
        Methods Ultrasonic indices were used to evaluate the severity of liver steatosis and fibrosis
        of participants from the NHANES database, respectively. The relationship between hsCAR and
        MAFLD was explored using multivariate logistic regression analysis, restricted cubic splines
        (RCS) as well as threshold analysis. Finally, subgroup analyses were performed using the same
        methodology.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Controlled attenuation parameter
  time frame: at baseline
  description: Controlled attenuation parameter is an ultrasound indicator measured by FibroScan to evaluate the degree of liver steatosis
  measure: Liver stiffness measurement
  time frame: at baseline
  description: Liver stiffness measurement is an ultrasound indicator measured by FibroScan to evaluate the degree of liver stiffness
  arm group label: Non-MAFLD group
  description: controlled attenuation parameter<274 dB/m
  arm group label: MAFLD group
  description: controlled attenuation parameter ≥ 274 dB/m
  arm group label: Non-fibrosis group
  description: liver stiffness measurement < 8.2 kPa
  arm group label: Fibrosis group
  description: liver stiffness measurement ≥ 8.2 kPa
  intervention type: Other
  intervention name: high-sensitivity C-reactive protein to albumin ratio
  description: High-sensitivity C-reactive protein to albumin ratio is an inflammatory indicator which can make a determination of disease severity.
  arm group label: Fibrosis group
  arm group label: MAFLD group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  last name: Tingqiu Wang, Bachelor
  role: Study Director
  affiliation: The Second Affiliated Hospital of Chongqing Medical University
  last name: Tingqiu Wang, Bachelor
  phone: +8617815370539
  email: w857683014@163.com
  last name: Zhigang Luo, Master
  phone: +8618989126596
  email: 306395@hospital.cqmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
  PMID: 32278004
  citation: Eddowes PJ, Sasso M, Allison M, Tsochatzis E, Anstee QM, Sheridan D, Guha IN, Cobbold JF, Deeks JJ, Paradis V, Bedossa P, Newsome PN. Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2019 May;156(6):1717-1730. doi: 10.1053/j.gastro.2019.01.042. Epub 2019 Jan 25.
  PMID: 30689971
  citation: Karimi A, Shobeiri P, Kulasinghe A, Rezaei N. Novel Systemic Inflammation Markers to Predict COVID-19 Prognosis. Front Immunol. 2021 Oct 22;12:741061. doi: 10.3389/fimmu.2021.741061. eCollection 2021.
  PMID: 34745112
  responsible party type: Principal Investigator
  investigator affiliation: Chongqing Medical University
  investigator full name: Tingqiu Wang
  investigator title: Principal Investigator
  mesh term: Liver Diseases
  mesh term: Fatty Liver
  mesh term: Non-alcoholic Fatty Liver Disease
  mesh term: Liver Cirrhosis
  sharing ipd: No