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/NCT05968235</url>
    </required_header>
    <id_info>
      <org_study_id>XJPF-LCY-V202307</org_study_id>
      <nct_id>NCT05968235</nct_id>
    </id_info>
    <brief_title>Correlation of Glucose and Lipid Metabolism Levels With Vitiligo</brief_title>
    <official_title>Association of Glucose and Lipid Metabolism Levels and Vitiligo : a Case-control Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Xijing Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Xijing Hospital</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>
        The goal of this observational study is to compare serum glucose and lipid metabolism levels&#xD;
        between health volunteers and vitiligo patients. The main question it aims to answer is&#xD;
        whether vitiligo is related to glucose and lipid metabolism disorders. Participants will&#xD;
        complete a vitiligo questionnaire and test serum levels of indicators related to glucose and&#xD;
        lipid metabolism. Researchers will compare vitiligo patients with healthy volunteers to see&#xD;
        if there is a correlation between vitiligo and disorders of glucose and lipid metabolism.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Vitiligo is a common autoimmune skin disease, which causes white spot formation due to&#xD;
        destruction of epidermal melanocytes, severely affecting the physical and mental health of&#xD;
        patients, but treatment is extremely difficult due to unclear pathogenesis. Studies have&#xD;
        reported that patients with type I diabetes mellitus combined with vitiligo, the risk of&#xD;
        metabolic syndrome, diabetes mellitus, elevated lipids, and obesity in vitiligo patients is&#xD;
        higher than that of healthy controls, and other studies have reported that vitiligo lesions&#xD;
        in patients with hypercholesterolemia combined with vitiligo treated with simvastatin get&#xD;
        rapid skin color, suggesting that there is a correlation between glucose and lipid metabolism&#xD;
        and the vitiligo disease, but as of now there is no research study on the correlation of&#xD;
        glucose and lipid metabolism and vitiligo pathogenesis, much less large data can be analyzed&#xD;
        for reference. Therefore, there is an urgent need to study the metabolic profile of vitiligo&#xD;
        patients and utilize the basic research platform to explore the role of abnormal body&#xD;
        metabolism in the onset or progression of vitiligo.&#xD;
  &#xD;
        This study intends to conduct a cross-sectional study, using questionnaires to collect and&#xD;
        register vitiligo patients' disease information, etc., to establish a database of study&#xD;
        subjects, and to collect peripheral blood samples from vitiligo patients to test the levels&#xD;
        of key indicators of glycolipid and lipid metabolism, and to analyze their correlation with&#xD;
        clinical features, disease activity, and treatment of vitiligo. Through the above studies,&#xD;
        clinical evidence for the involvement of abnormalities in glycolipid and lipid metabolism in&#xD;
        the development of vitiligo was provided.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2020</start_date>
    <completion_date type="Actual">March 25, 2023</completion_date>
    <primary_completion_date type="Actual">March 25, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Demographic and epidemiological information of the study subjects</measure>
      <time_frame>2020.02.01-2023.03.25</time_frame>
      <description>Detailed records of demographic information (age, gender, occupation, education degree, life history, et al.), clinical information of vitiligo (age at onset, duration, severity, type, treatment, complication, et al.) and physical examination index (height, weight, blood pressure, heart rate).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum glucose and lipid metabolism levels of the study subjects</measure>
      <time_frame>2020.02.01-2023.03.25</time_frame>
      <description>Detection of fasting blood glucose, glycosylated hemoglobin, triglycerides, total cholesterol, high-density lipoproteins, and low-density lipoproteins in peripheral blood of study subjects.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">963</enrollment>
    <condition>Metabolism Disorder, Glucose</condition>
    <condition>Metabolism Disorder, Lipid</condition>
    <condition>Vitiligo</condition>
    <arm_group>
      <arm_group_label>Vitiligo</arm_group_label>
      <description>Patients diagnosed with vitiligo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy</arm_group_label>
      <description>Healthy volunteers with sex- and age-matched with vitiligo patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Collecting blood samples</intervention_name>
      <description>Peripheral blood was collected from the study subjects and blood glucose, glycosylated hemoglobin, triglycerides, total cholesterol, high-density lipoprotein and low-density lipoprotein levels were measured in the peripheral blood.</description>
      <arm_group_label>Healthy</arm_group_label>
      <arm_group_label>Vitiligo</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood samples of vitiligo patients and healthy volunteers&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          We recruited patients with clinically diagnosed vitiligo and age- and sex-matched healthy&#xD;
          volunteers.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients diagnosed as vitiligo by a dermatologist based on a combination of clinical&#xD;
               manifestations (milky white or porcelain white patches), Wood's Lamp test results&#xD;
               (bright white fluorescence), and histopathologic test results (reduction or&#xD;
               disappearance of epidermal melanocytes in the white patches);&#xD;
  &#xD;
            2. Male or female subjects, age between 18 and 60 years old;&#xD;
  &#xD;
            3. Stable vital signs;&#xD;
  &#xD;
            4. Study subjects voluntarily signed an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects who have been systematically using glucocorticoids, immunosuppressants, etc.&#xD;
               that affect glycolipid levels due to a combination of diseases other than metabolic&#xD;
               diseases in the last 3 months shall be asked and determined by a clinician;&#xD;
  &#xD;
            2. Women who are pregnant or breastfeeding shall be asked and determined by a clinician;&#xD;
  &#xD;
            3. Subjects who suffer from psychiatric disorders, etc. and who are not capable of&#xD;
               cooperating with the follow-up study shall be asked and determined by a clinician.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chunying Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>Air Force Military Medical University, China</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Xijing Hospital</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>710032</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Xijing Hospital</investigator_affiliation>
      <investigator_full_name>Li Chunying-1</investigator_full_name>
      <investigator_title>Vice Chief</investigator_title>
    </responsible_party>
    <keyword>Vitiligo</keyword>
    <keyword>Glucose</keyword>
    <keyword>Lipid</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitiligo</mesh_term>
      <mesh_term>Metabolic Diseases</mesh_term>
      <mesh_term>Glucose Metabolism Disorders</mesh_term>
      <mesh_term>Lipid Metabolism Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05968235
  org study id: XJPF-LCY-V202307
  nct id: NCT05968235
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to compare serum glucose and lipid metabolism levels
        between health volunteers and vitiligo patients. The main question it aims to answer is
        whether vitiligo is related to glucose and lipid metabolism disorders. Participants will
        complete a vitiligo questionnaire and test serum levels of indicators related to glucose and
        lipid metabolism. Researchers will compare vitiligo patients with healthy volunteers to see
        if there is a correlation between vitiligo and disorders of glucose and lipid metabolism.
  Vitiligo is a common autoimmune skin disease, which causes white spot formation due to
        destruction of epidermal melanocytes, severely affecting the physical and mental health of
        patients, but treatment is extremely difficult due to unclear pathogenesis. Studies have
        reported that patients with type I diabetes mellitus combined with vitiligo, the risk of
        metabolic syndrome, diabetes mellitus, elevated lipids, and obesity in vitiligo patients is
        higher than that of healthy controls, and other studies have reported that vitiligo lesions
        in patients with hypercholesterolemia combined with vitiligo treated with simvastatin get
        rapid skin color, suggesting that there is a correlation between glucose and lipid metabolism
        and the vitiligo disease, but as of now there is no research study on the correlation of
        glucose and lipid metabolism and vitiligo pathogenesis, much less large data can be analyzed
        for reference. Therefore, there is an urgent need to study the metabolic profile of vitiligo
        patients and utilize the basic research platform to explore the role of abnormal body
        metabolism in the onset or progression of vitiligo.
  
        This study intends to conduct a cross-sectional study, using questionnaires to collect and
        register vitiligo patients' disease information, etc., to establish a database of study
        subjects, and to collect peripheral blood samples from vitiligo patients to test the levels
        of key indicators of glycolipid and lipid metabolism, and to analyze their correlation with
        clinical features, disease activity, and treatment of vitiligo. Through the above studies,
        clinical evidence for the involvement of abnormalities in glycolipid and lipid metabolism in
        the development of vitiligo was provided.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Demographic and epidemiological information of the study subjects
  time frame: 2020.02.01-2023.03.25
  description: Detailed records of demographic information (age, gender, occupation, education degree, life history, et al.), clinical information of vitiligo (age at onset, duration, severity, type, treatment, complication, et al.) and physical examination index (height, weight, blood pressure, heart rate).
  measure: Serum glucose and lipid metabolism levels of the study subjects
  time frame: 2020.02.01-2023.03.25
  description: Detection of fasting blood glucose, glycosylated hemoglobin, triglycerides, total cholesterol, high-density lipoproteins, and low-density lipoproteins in peripheral blood of study subjects.
  arm group label: Vitiligo
  description: Patients diagnosed with vitiligo
  arm group label: Healthy
  description: Healthy volunteers with sex- and age-matched with vitiligo patients
  intervention type: Other
  intervention name: Collecting blood samples
  description: Peripheral blood was collected from the study subjects and blood glucose, glycosylated hemoglobin, triglycerides, total cholesterol, high-density lipoprotein and low-density lipoprotein levels were measured in the peripheral blood.
  arm group label: Healthy
  arm group label: Vitiligo
  Blood samples of vitiligo patients and healthy volunteers
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chunying Li
  role: Principal Investigator
  affiliation: Air Force Military Medical University, China
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Xijing Hospital
  investigator full name: Li Chunying-1
  investigator title: Vice Chief
  mesh term: Vitiligo
  mesh term: Metabolic Diseases
  mesh term: Glucose Metabolism Disorders
  mesh term: Lipid Metabolism Disorders
  sharing ipd: Undecided