<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/NCT03821961</url>
  </required_header>
  <id_info>
    <org_study_id>STARDOM-PET</org_study_id>
    <nct_id>NCT03821961</nct_id>
  </id_info>
  <brief_title>18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery</brief_title>
  <official_title>The Effect of Metabolic Surgery on the Endocrine Function of Pancreas: Clinical Value of 18F-FDOPA PET/CT Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea University Anam Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Myungmoon Pharma. Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Korea University Anam Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 aim of the study is to compare the endocrine function of pancreas between pre and post&#xD;
      metabolic surgery in patients with type 2 diabetes or prediabetes. The study will examine the&#xD;
      endocrine function of pancreas using 18F-FDOPA PET/CT imaging and various biochemical&#xD;
      laboratory tests&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 3, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Uptake value of 18F-FDOPA PET/CT from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Standardized Uptake Value</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Glycated Hemoglobin from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting Plasma Glucose from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in c-peptide level from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Insulinogenic index from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>(insulin30 min - insulinfasting)/(glucose30 min - glucosefasting)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>(insulinfasting × glucosefasting)/405</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Matsuda index from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI) from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Systolic Blood Pressure from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum level of HDL cholesterol from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum level of Triglycerides from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum level of LDL cholesterol from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum level of Total Cholesterol from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum level of High-sensitivity C-reactive Protein</measure>
    <time_frame>6 months</time_frame>
    <description>percent change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of diabetes medication from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>number of medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dosage of diabetes medication from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Dosage of medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of hypertension medication from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>number of medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dosage of hypertension medication from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Dosage of medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of dyslipidemia medication from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>number of medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dosage of dyslipidemia medication from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Dosage of medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum level of amino acid metabolites from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>glucose homeostasis and energy expenditure related metabolites</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in BDI scores of questionnaire from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDRS scores of questionnaire from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-36 scores of questionnaire from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>36 Item Short Form Survery(Scale for quality of life)(Higer values represent a worse outcome) (Score range for physical health, 0-400) (Score range for mental health, 0-400)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in IWQOL scores of questionnaire from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Impact of Weight on Quality of Life(Score range, 31-155)(Higer values represent a worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MAQOL scores of questionnaire from baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Moorehead-Ardelt Quality of Life(Score range, -3 to 3)(Higer values represent a better outcome)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>PreDiabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Metabolic surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Roux-en-Y gastric bypass, Sleeve gastrectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Metabolic Surgery</intervention_name>
    <description>Roux-en-Y gastric bypass, Sleeve gastrectomy</description>
    <arm_group_label>Metabolic surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes or prediabetes&#xD;
&#xD;
          -  Body mass index &gt;25.0 kg/m2&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes induced by chronic pancreatitis or pancreas cancer&#xD;
&#xD;
          -  Chronic glucocorticoid usage&#xD;
&#xD;
          -  Significant coronary artery disease or cerebrovascular disease within the previous 3&#xD;
             months&#xD;
&#xD;
          -  Uncompensated congestive heart failure&#xD;
&#xD;
          -  Severe pulmonary disease defined as FEV1 &lt; 50% of predicted value&#xD;
&#xD;
          -  End stage renal disease on dialysis&#xD;
&#xD;
          -  Acute infectious disease within the previous 3 months&#xD;
&#xD;
          -  Pulmonary thromboembolism or thrombophlebitis within the previous 3 months&#xD;
&#xD;
          -  History of cancer (except for basal cell skin cancer or cancer in situ)&#xD;
&#xD;
          -  Prior gastrointestinal surgery (except for appendectomy or hemorrhoidectomy)&#xD;
&#xD;
          -  Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease&#xD;
&#xD;
          -  History of chronic liver disease (except for NAFLD/NASH)&#xD;
&#xD;
          -  Psychiatric disorders including dementia, active psychosis, severe depression&#xD;
             requiring &gt; 2 medications, history of suicide attempts, alcohol or drug abuse within&#xD;
             the previous 5 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sungsoo Park, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Anam Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yeongkeun Kwon, MD, PhD</last_name>
    <phone>+82 2 920 5027</phone>
    <email>kukwon@korea.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yeongkeun Kwon, MD, PhD</last_name>
      <phone>+82 2 920 5027</phone>
      <email>kukwon@korea.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 23, 2020</last_update_submitted>
  <last_update_submitted_qc>February 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Korea University Anam Hospital</investigator_affiliation>
    <investigator_full_name>Sungsoo Park</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>PreDiabetes</keyword>
  <keyword>Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</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/NCT03821961
org study id: STARDOM-PET
nct id: NCT03821961
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to compare the endocrine function of pancreas between pre and post
      metabolic surgery in patients with type 2 diabetes or prediabetes. The study will examine the
      endocrine function of pancreas using 18F-FDOPA PET/CT imaging and various biochemical
      laboratory tests
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Uptake value of 18F-FDOPA PET/CT from baseline
time frame: 6 months
description: Standardized Uptake Value
measure: Change in Glycated Hemoglobin from baseline
time frame: 6 months
description: percent change
measure: Change in Fasting Plasma Glucose from baseline
time frame: 6 months
description: percent change
measure: Changes in c-peptide level from baseline
time frame: 6 months
description: percent change
measure: Changes in Insulinogenic index from baseline
time frame: 6 months
description: (insulin30 min - insulinfasting)/(glucose30 min - glucosefasting)
measure: Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline
time frame: 6 months
description: (insulinfasting × glucosefasting)/405
measure: Changes in Matsuda index from baseline
time frame: 6 months
description: Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)
measure: Change in Body Mass Index (BMI) from baseline
time frame: 6 months
description: percent change
measure: Change in Systolic Blood Pressure from baseline
time frame: 6 months
description: percent change
measure: Change in serum level of HDL cholesterol from baseline
time frame: 6 months
description: percent change
measure: Change in serum level of Triglycerides from baseline
time frame: 6 months
description: percent change
measure: Change in serum level of LDL cholesterol from baseline
time frame: 6 months
description: percent change
measure: Change in serum level of Total Cholesterol from baseline
time frame: 6 months
description: percent change
measure: Change in serum level of High-sensitivity C-reactive Protein
time frame: 6 months
description: percent change
measure: Change in number of diabetes medication from baseline
time frame: 6 months
description: number of medication
measure: Change in dosage of diabetes medication from baseline
time frame: 6 months
description: Dosage of medication
measure: Change in number of hypertension medication from baseline
time frame: 6 months
description: number of medication
measure: Change in dosage of hypertension medication from baseline
time frame: 6 months
description: Dosage of medication
measure: Change in number of dyslipidemia medication from baseline
time frame: 6 months
description: number of medication
measure: Change in dosage of dyslipidemia medication from baseline
time frame: 6 months
description: Dosage of medication
measure: Change in serum level of amino acid metabolites from baseline
time frame: 6 months
description: glucose homeostasis and energy expenditure related metabolites
measure: Change in BDI scores of questionnaire from baseline
time frame: 6 months
description: Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)
measure: Change in HDRS scores of questionnaire from baseline
time frame: 6 months
description: Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)
measure: Change in SF-36 scores of questionnaire from baseline
time frame: 6 months
description: 36 Item Short Form Survery(Scale for quality of life)(Higer values represent a worse outcome) (Score range for physical health, 0-400) (Score range for mental health, 0-400)
measure: Change in IWQOL scores of questionnaire from baseline
time frame: 6 months
description: Impact of Weight on Quality of Life(Score range, 31-155)(Higer values represent a worse outcome)
measure: Change in MAQOL scores of questionnaire from baseline
time frame: 6 months
description: Moorehead-Ardelt Quality of Life(Score range, -3 to 3)(Higer values represent a better outcome)
arm group label: Metabolic surgery
arm group type: Experimental
description: Roux-en-Y gastric bypass, Sleeve gastrectomy
intervention type: Procedure
intervention name: Metabolic Surgery
description: Roux-en-Y gastric bypass, Sleeve gastrectomy
arm group label: Metabolic surgery
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sungsoo Park, MD, PhD
role: Principal Investigator
affiliation: Korea University Anam Hospital
last name: Yeongkeun Kwon, MD, PhD
phone: +82 2 920 5027
email: kukwon@korea.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Korea University Anam Hospital
investigator full name: Sungsoo Park
investigator title: Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: No