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/NCT05980754</url>
    </required_header>
    <id_info>
      <org_study_id>DCTC-IIR202305</org_study_id>
      <nct_id>NCT05980754</nct_id>
    </id_info>
    <brief_title>Clinical Study on Exploring High Risk Factors Inducing the Progress of Diabetes</brief_title>
    <official_title>Clinical Study on Exploring High Risk Factors Inducing the Progress of Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third 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>
        Explore the high related factors of impaired glucose tolerance through descriptive statistics&#xD;
        and analysis of variance.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a cross-sectional study planned to include healthy individuals with a BMI&#xD;
        within the normal range (18.5&lt;BMI&lt;24 kg/m2) (HbA1c ≤ 5.6%, n=18), pre diabetic patients (5.7%&#xD;
        ≤ HbA1c ≤ 6.4%, n=36), and T2DM patients (HbA1c ≥ 6.5%, n=36) among individuals who meet the&#xD;
        inclusion criteria and undergo annual physical examinations at the Physical Examination&#xD;
        Center of the Third Hospital of Beijing Medical University. Collect the examination values&#xD;
        related to demography and glucose metabolism balance of physical examination items, and carry&#xD;
        out magnetic resonance imaging (MRI) imaging examination and oral glucose tolerance test&#xD;
        (OGTT) results. Explore the high related factors of impaired glucose tolerance through&#xD;
        descriptive statistics and analysis of variance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2025</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>biochemical parameters including level of Glucose</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>level of Glucose</description>
    </primary_outcome>
    <primary_outcome>
      <measure>biochemical parameters including level of C-peptide</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>level of C-peptide</description>
    </primary_outcome>
    <primary_outcome>
      <measure>biochemical parameters including level of insulin</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>level of insulin</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Liver fat content</measure>
      <time_frame>1 year</time_frame>
      <description>magnetic resonance imaging proton density fat fraction (MRI-PDFF)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pancreatic fat content</measure>
      <time_frame>1 year</time_frame>
      <description>magnetic resonance imaging proton density fat fraction (MRI-PDFF)</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>T2D</condition>
    <arm_group>
      <arm_group_label>Healthy group</arm_group_label>
      <description>No intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>pre diabetic patients</arm_group_label>
      <description>No intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>T2DM patients</arm_group_label>
      <description>No intervention</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Annual physical examination population conducted by the Physical Examination Center of the&#xD;
          Third Hospital of Beijing Medical University&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • The diagnostic criteria of the American diabetes Association (ADA) were used to determine&#xD;
          the type of subjects: Group Healthy individuals: Glycated hemoglobin (HbA1c) ≤ 5.6%; Group&#xD;
          Pre T2DM patients: 5.7% ≤ HbA1c ≤ 6.4%; Group T2DM patients: HbA1c ≥ 6.5% (for T2DM&#xD;
          patients: this study needs to include first-time or previously diagnosed patients who have&#xD;
          not used hypoglycemic drugs within 4 years and HBA1C ≤ 9.5%)Clinical diagnosis of&#xD;
          Alzheimer's Disease.&#xD;
  &#xD;
            -  Male weight ≥ 50kg, female weight ≥ 45kg, 18.5 &lt; BMI &lt; 24kg/m2&#xD;
  &#xD;
            -  Age range from 40 years old (inclusive) to 65 years old (inclusive), with no less than&#xD;
               one-third of either gender&#xD;
  &#xD;
            -  Subjects voluntarily sign informed consent forms, can maintain good communication with&#xD;
               researchers, and comply with the requirements of clinical trials&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  In the past month and currently taking glucocorticoids, steroids, thiazide diuretics,&#xD;
               or atypical antipsychotic drugs&#xD;
  &#xD;
            -  Some diseases that affect glucose tolerance: type 1 diabetes (T1DM), pancreatic&#xD;
               exocrine disease, polycystic ovary syndrome and other endocrine diseases, autoimmune&#xD;
               diseases, infection and trauma and other irritability factors&#xD;
  &#xD;
            -  Diseases that may affect eating: mental illness, post gastrectomy, inflammatory bowel&#xD;
               disease, uncontrolled thyroid disease.&#xD;
  &#xD;
            -  Healthy subjects with a history of gestational diabetes or subjects with direct family&#xD;
               members with a family history of diabetes&#xD;
  &#xD;
            -  Pregnant or lactating women&#xD;
  &#xD;
            -  Participate in any other clinical trials within 3 months prior to the trial&#xD;
  &#xD;
            -  Blood donation or loss of ≥ 400mL within 8 weeks before the first cycle of the&#xD;
               experiment&#xD;
  &#xD;
            -  Clinically significant history of ECG abnormalities or family history of long QT&#xD;
               syndrome (grandparents, parents, siblings) Suffering from any condition that&#xD;
               significantly affects glucose absorption, distribution, metabolism, and excretion&#xD;
               within 2 weeks prior to the experiment, or any condition that may pose a hazard to the&#xD;
               subject, the detailed conditions are as follows:&#xD;
  &#xD;
                 1. History of inflammatory bowel disease, gastritis, ulcers, gastrointestinal or&#xD;
                    rectal bleeding&#xD;
  &#xD;
                 2. A significant history of gastrointestinal surgery (such as gastrectomy,&#xD;
                    gastroenterostomy, or intestinal resection),&#xD;
  &#xD;
                 3. history of pancreatic injury or pancreatitis or clinical evidence, or&#xD;
                    researchers' judgment of abnormal lipase and amylase,&#xD;
  &#xD;
                 4. abnormal liver function tests (such as ALT, AST, serum bilirubin), which are&#xD;
                    clinically significant, indicate liver disease, cirrhosis, or liver injury.&#xD;
                    (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline&#xD;
                    phosphatase [ALP], glutamine transpeptidase [GGT], total bilirubin) greater than&#xD;
                    three times their respective upper limit of normal (ULN).&#xD;
  &#xD;
                 5. There is a history or evidence of renal dysfunction, manifested as clinically&#xD;
                    significant creatinine or urinary composition abnormalities (such as tubular&#xD;
                    type), or eGFR&lt;60 ml/min/1.73m2&#xD;
  &#xD;
                 6. Urinary tract obstruction or difficulty in emptying urine during screening period&#xD;
  &#xD;
            -  Individuals with any form of medical/implant intolerance, including pacemakers, metal&#xD;
               plates, or magnetic resonance imaging (MRI)&#xD;
  &#xD;
            -  Individuals who have tested positive for human immunodeficiency virus (HIV)&#xD;
               antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies,&#xD;
               or syphilis (results within six months are exempt from testing)&#xD;
  &#xD;
            -  Smokers who smoke more than 10 cigarettes or an equivalent amount of tobacco per day&#xD;
               cannot stop smoking during the trial period&#xD;
  &#xD;
            -  There is a history of drug or alcohol abuse within the 12 months prior to the trial,&#xD;
               or evidence of abuse is found during laboratory testing during screening evaluation&#xD;
  &#xD;
            -  During screening, lying blood pressure (after resting for 5 minutes) exceeds the range&#xD;
               of 90-140mm Hg (including 90140) in systolic blood pressure, 50-90 mmHg (including 50,&#xD;
               90) in diastolic blood pressure, or heart rate (HR) exceeds the range of 50 bpm to 100&#xD;
               bpm (including 50100) in heart rate (HR)&#xD;
  &#xD;
            -  Tumor patients&#xD;
  &#xD;
            -  Participants are not suitable for the experiment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University Third Hospital</investigator_affiliation>
      <investigator_full_name>Dongyang Liu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <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/NCT05980754
  org study id: DCTC-IIR202305
  nct id: NCT05980754
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Explore the high related factors of impaired glucose tolerance through descriptive statistics
        and analysis of variance.
  This study is a cross-sectional study planned to include healthy individuals with a BMI
        within the normal range (18.5<BMI<24 kg/m2) (HbA1c ≤ 5.6%, n=18), pre diabetic patients (5.7%
        ≤ HbA1c ≤ 6.4%, n=36), and T2DM patients (HbA1c ≥ 6.5%, n=36) among individuals who meet the
        inclusion criteria and undergo annual physical examinations at the Physical Examination
        Center of the Third Hospital of Beijing Medical University. Collect the examination values
        related to demography and glucose metabolism balance of physical examination items, and carry
        out magnetic resonance imaging (MRI) imaging examination and oral glucose tolerance test
        (OGTT) results. Explore the high related factors of impaired glucose tolerance through
        descriptive statistics and analysis of variance.
  observational model: Other
  time perspective: Cross-Sectional
  measure: biochemical parameters including level of Glucose
  time frame: through study completion, an average of 1 year
  description: level of Glucose
  measure: biochemical parameters including level of C-peptide
  time frame: through study completion, an average of 1 year
  description: level of C-peptide
  measure: biochemical parameters including level of insulin
  time frame: through study completion, an average of 1 year
  description: level of insulin
  measure: Liver fat content
  time frame: 1 year
  description: magnetic resonance imaging proton density fat fraction (MRI-PDFF)
  measure: pancreatic fat content
  time frame: 1 year
  description: magnetic resonance imaging proton density fat fraction (MRI-PDFF)
  arm group label: Healthy group
  description: No intervention
  arm group label: pre diabetic patients
  description: No intervention
  arm group label: T2DM patients
  description: No intervention
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Peking University Third Hospital
  investigator full name: Dongyang Liu
  investigator title: Principal Investigator
  sharing ipd: Undecided