<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/NCT04462081</url>
  </required_header>
  <id_info>
    <org_study_id>NAFLD and CHD in Diabetes</org_study_id>
    <nct_id>NCT04462081</nct_id>
  </id_info>
  <brief_title>Non Alcoholic Fatty Liver Disease and Coronary Heart Disease in Type 2 Diabetes Patients</brief_title>
  <official_title>Non Alcoholic Fatty Liver Disease and Coronary Heart Disease in Type 2 Diabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the feasibility in diabetics in a primary care setting of screening for NAFLD and&#xD;
      advanced fibrosis, by using non-invasive magnetic resonance imaging (MRI) to estimate the&#xD;
      hepatic proton density fat fraction (MRI-PDFF) and magnetic resonance elastography (MRE) to&#xD;
      estimate hepatic stiffness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective cohort study consisting of a one-time visit by diabetic patients with&#xD;
      optional following liver biopsy. The aim of the study is to evaluate whether liver fat&#xD;
      fraction and liver stiffness, as determined by magnetic resonance imaging, are associated&#xD;
      with subclinical cardiovascular disease, as evaluated by coronary artery calcium scan in&#xD;
      diabetics. During the visit, patients will undergo review of medical history, vitals&#xD;
      (including body mass index, blood pressure), physical exam, blood work, urine collection,&#xD;
      ECG, magnetic resonance imaging (MRI), including MR proton density fat fraction (MRI-PDFF)&#xD;
      and MR elastography, ultrasound using acoustic radiation force impulse (ARFI) imaging, and&#xD;
      computed tomography (CT) scan for coronary artery calcium scoring. Blood work will be sent&#xD;
      for labs relevant to traits of metabolic syndrome including markers for diabetes (hemoglobin&#xD;
      A1C, fasting glucose) and hyperlipidemia (lipid panel). Serum, plasma and whole blood will be&#xD;
      stored for future studies. Results from history, physical exam, and radiographic imaging will&#xD;
      be analyzed and if they indicate the presence of nonalcoholic steatohepatitis, patients will&#xD;
      be offered an optional liver biopsy for further assessment. All patients will be invited to&#xD;
      continue in the study and have follow-up visits every two years for a total duration of the&#xD;
      study of 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Liver Fat as Measured by MRI-PDFF</measure>
    <time_frame>Baseline</time_frame>
    <description>Evaluation of liver fat fraction and liver stiffness, as determined by magnetic resonance imaging, are associated with subclinical cardiovascular disease, as evaluated by coronary artery calcium scan in diabetics</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Nonalcoholic Steatohepatitis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      There is a separate optional component of the study where subjects will be asked to donate a&#xD;
      blood sample for genetic research.Subjects will be offered the opportunity to review, discuss&#xD;
      and sign the consent at their scheduled visit. All questions will be answered at this time&#xD;
      and throughout the study. Declining to give a genetic sample does not prohibit the&#xD;
      participant from participating in the study. The biospecimen collected as part of this study&#xD;
      will be kept in Dr. Loomba's locked research freezer at the Clinical Teaching Facility&#xD;
      (CTF-building A).These samples and data may be stored for 50 years to be used at a later date&#xD;
      for investigation of new novel biomarkers. This will be made clear to the patient during the&#xD;
      consent process.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults, age 21 or above, with diagnosis of T2DM according to the American Diabetes&#xD;
        Association (ADA) clinical practice recommendations.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adults, age 21 or above, with diagnosis of T2DM according to the American Diabetes&#xD;
             Association (ADA) clinical practice recommendations.&#xD;
&#xD;
          -  T2DM is defined according to American Diabetes Association (ADA) clinical practice&#xD;
             recommendations if one of the following criteria is met:&#xD;
&#xD;
               -  Diabetes symptoms (polyuria, polydipsia, polyphagia, increased fatigue, weight&#xD;
                  loss, blurred vision) exist and casual plasma glucose ≥200 mg/dl (11.1 mmol/l) OR&#xD;
&#xD;
               -  Fasting plasma glucose (FPG) ≥126 mg/dl (7.0 mmol/l); OR&#xD;
&#xD;
               -  Plasma glucose ≥200 mg/dl (11.1 mmol/l) during a 75-g oral glucose tolerance test&#xD;
                  (OGTT) (25).&#xD;
&#xD;
          -  If any of these test results occur, testing should be repeated on a different day to&#xD;
             confirm the diagnosis. OR&#xD;
&#xD;
               -  hemoglobin A1C (HbA1C) ≥6.5% (26).&#xD;
&#xD;
          -  The subject is fully informed and willing and able to perform all the procedures&#xD;
             specified in the protocol and signed a written informed consent to participate&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Documented history of cardiovascular disease (CVD), such as acute coronary syndrome&#xD;
             (ST elevation myocardial infarction, non-ST elevation myocardial infarction, unstable&#xD;
             angina), stable angina, history of angioplasty or stent placement, cerebrovascular&#xD;
             disease (ischemic or hemorrhagic stroke), and peripheral vascular disease.&#xD;
&#xD;
          -  History of congestive heart failure&#xD;
&#xD;
          -  Evidence of other causes of chronic liver disease&#xD;
&#xD;
               -  Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).&#xD;
&#xD;
               -  Previous or current infection with Hepatitis C as defined by presence of&#xD;
                  hepatitis C virus Ab in serum (anti-HCV Ab).&#xD;
&#xD;
               -  Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or&#xD;
                  greater and liver histology consistent with autoimmune hepatitis or previous&#xD;
                  response to immunosuppressive therapy.&#xD;
&#xD;
               -  Autoimmune cholestatic liver disorders as defined by elevation of alkaline&#xD;
                  phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver&#xD;
                  histology consistent with primary biliary cirrhosis or elevation of alkaline&#xD;
                  phosphatase and liver histology consistent with sclerosing cholangitis.&#xD;
&#xD;
               -  Wilson disease as defined by ceruloplasmin below the limits of normal and liver&#xD;
                  histology consistent with Wilson disease.&#xD;
&#xD;
               -  Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than&#xD;
                  normal and liver histology consistent with alpha-1-antitrypsin deficiency.&#xD;
&#xD;
               -  Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy&#xD;
                  and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.&#xD;
&#xD;
               -  Drug-induced liver disease as defined on the basis of typical exposure and&#xD;
                  history.&#xD;
&#xD;
               -  Bile duct obstruction as shown by imaging studies.&#xD;
&#xD;
          -  History of gastrointestinal bypass surgery or ingestion of medications known to&#xD;
             produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen,&#xD;
             methotrexate, amiodarone or tetracycline in the previous 6 months.&#xD;
&#xD;
          -  Evidence of cirrhosis or previously known cirrhosis based on the results from previous&#xD;
             liver biopsy or history of portal hypertension presented by ascites, hepatic&#xD;
             encephalopathy or varices&#xD;
&#xD;
          -  Absence of regular and/or excessive use of alcohol(defined as &gt;30g/day for males and&#xD;
             &gt;15g/day for females) for a period longer than 2 years at any times in the last 10&#xD;
             years&#xD;
&#xD;
          -  Serum creatinine&gt; 1.5 mg/dL&#xD;
&#xD;
          -  The subject is a pregnant or nursing female&#xD;
&#xD;
          -  Contraindications to computed tomography (CT) or magnetic resonance imaging (MRI):&#xD;
&#xD;
               -  The subject has any contraindication to MR imaging, such as patients with cardiac&#xD;
                  pacemaker or defibrillator, neurostimulator, intravascular stents, coils, valves,&#xD;
                  surgical clips, implanted electronic infusion pump, ferromagnetic foreign body or&#xD;
                  other conditions that would preclude proximity to a strong magnetic field.&#xD;
&#xD;
               -  The subject has a history of extreme claustrophobia.&#xD;
&#xD;
               -  The subject cannot fit inside the MRI or CT machine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rohit Loomba</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>December 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Rohit Loomba</investigator_full_name>
    <investigator_title>Associate Professor of Clinical Medicine</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>Heart Diseases</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04462081
org study id: NAFLD and CHD in Diabetes
nct id: NCT04462081
lead sponsor: 
has dmc: No
To assess the feasibility in diabetics in a primary care setting of screening for NAFLD and
      advanced fibrosis, by using non-invasive magnetic resonance imaging (MRI) to estimate the
      hepatic proton density fat fraction (MRI-PDFF) and magnetic resonance elastography (MRE) to
      estimate hepatic stiffness.
This is a prospective cohort study consisting of a one-time visit by diabetic patients with
      optional following liver biopsy. The aim of the study is to evaluate whether liver fat
      fraction and liver stiffness, as determined by magnetic resonance imaging, are associated
      with subclinical cardiovascular disease, as evaluated by coronary artery calcium scan in
      diabetics. During the visit, patients will undergo review of medical history, vitals
      (including body mass index, blood pressure), physical exam, blood work, urine collection,
      ECG, magnetic resonance imaging (MRI), including MR proton density fat fraction (MRI-PDFF)
      and MR elastography, ultrasound using acoustic radiation force impulse (ARFI) imaging, and
      computed tomography (CT) scan for coronary artery calcium scoring. Blood work will be sent
      for labs relevant to traits of metabolic syndrome including markers for diabetes (hemoglobin
      A1C, fasting glucose) and hyperlipidemia (lipid panel). Serum, plasma and whole blood will be
      stored for future studies. Results from history, physical exam, and radiographic imaging will
      be analyzed and if they indicate the presence of nonalcoholic steatohepatitis, patients will
      be offered an optional liver biopsy for further assessment. All patients will be invited to
      continue in the study and have follow-up visits every two years for a total duration of the
      study of 5 years.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Liver Fat as Measured by MRI-PDFF
time frame: Baseline
description: Evaluation of liver fat fraction and liver stiffness, as determined by magnetic resonance imaging, are associated with subclinical cardiovascular disease, as evaluated by coronary artery calcium scan in diabetics
There is a separate optional component of the study where subjects will be asked to donate a
      blood sample for genetic research.Subjects will be offered the opportunity to review, discuss
      and sign the consent at their scheduled visit. All questions will be answered at this time
      and throughout the study. Declining to give a genetic sample does not prohibit the
      participant from participating in the study. The biospecimen collected as part of this study
      will be kept in Dr. Loomba's locked research freezer at the Clinical Teaching Facility
      (CTF-building A).These samples and data may be stored for 50 years to be used at a later date
      for investigation of new novel biomarkers. This will be made clear to the patient during the
      consent process.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Rohit Loomba
role: Principal Investigator
affiliation: University of California, San Diego
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Rohit Loomba
investigator title: Associate Professor of Clinical Medicine
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Heart Diseases
mesh term: Coronary Disease
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
sharing ipd: No