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18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821961
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
Myungmoon Pharma. Co. Ltd.
Information provided by (Responsible Party):
Sungsoo Park, Korea University Anam Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 PreDiabetes Obesity Procedure: Metabolic Surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Metabolic Surgery on the Endocrine Function of Pancreas: Clinical Value of 18F-FDOPA PET/CT Imaging
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metabolic surgery
Roux-en-Y gastric bypass, Sleeve gastrectomy
Procedure: Metabolic Surgery
Roux-en-Y gastric bypass, Sleeve gastrectomy




Primary Outcome Measures :
  1. Change in Uptake value of 18F-FDOPA PET/CT from baseline [ Time Frame: 6 months ]
    Standardized Uptake Value


Secondary Outcome Measures :
  1. Change in Glycated Hemoglobin from baseline [ Time Frame: 6 months ]
    percent change

  2. Change in Fasting Plasma Glucose from baseline [ Time Frame: 6 months ]
    percent change

  3. Changes in c-peptide level from baseline [ Time Frame: 6 months ]
    percent change

  4. Changes in Insulinogenic index from baseline [ Time Frame: 6 months ]
    (insulin30 min − insulinfasting)/(glucose30 min − glucosefasting)

  5. Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline [ Time Frame: 6 months ]
    (insulinfasting × glucosefasting)/405

  6. Changes in Matsuda index from baseline [ Time Frame: 6 months ]
    Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)

  7. Change in Body Mass Index (BMI) from baseline [ Time Frame: 6 months ]
    percent change

  8. Change in Systolic Blood Pressure from baseline [ Time Frame: 6 months ]
    percent change

  9. Change in serum level of HDL cholesterol from baseline [ Time Frame: 6 months ]
    percent change

  10. Change in serum level of Triglycerides from baseline [ Time Frame: 6 months ]
    percent change

  11. Change in serum level of LDL cholesterol from baseline [ Time Frame: 6 months ]
    percent change

  12. Change in serum level of Total Cholesterol from baseline [ Time Frame: 6 months ]
    percent change

  13. Change in serum level of High-sensitivity C-reactive Protein [ Time Frame: 6 months ]
    percent change

  14. Change in number of diabetes medication from baseline [ Time Frame: 6 months ]
    number of medication

  15. Change in dosage of diabetes medication from baseline [ Time Frame: 6 months ]
    Dosage of medication

  16. Change in number of hypertension medication from baseline [ Time Frame: 6 months ]
    number of medication

  17. Change in dosage of hypertension medication from baseline [ Time Frame: 6 months ]
    Dosage of medication

  18. Change in number of dyslipidemia medication from baseline [ Time Frame: 6 months ]
    number of medication

  19. Change in dosage of dyslipidemia medication from baseline [ Time Frame: 6 months ]
    Dosage of medication

  20. Change in serum level of amino acid metabolites from baseline [ Time Frame: 6 months ]
    glucose homeostasis and energy expenditure related metabolites

  21. Change in BDI scores of questionnaire from baseline [ Time Frame: 6 months ]
    Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)

  22. Change in HDRS scores of questionnaire from baseline [ Time Frame: 6 months ]
    Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)

  23. Change in SF-36 scores of questionnaire from baseline [ Time Frame: 6 months ]
    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)

  24. Change in IWQOL scores of questionnaire from baseline [ Time Frame: 6 months ]
    Impact of Weight on Quality of Life(Score range, 31-155)(Higer values represent a worse outcome)

  25. Change in MAQOL scores of questionnaire from baseline [ Time Frame: 6 months ]
    Moorehead-Ardelt Quality of Life(Score range, -3 to 3)(Higer values represent a better outcome)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 diabetes or prediabetes
  • Body mass index >25.0 kg/m2
  • Written informed consent

Exclusion Criteria:

  • Diabetes induced by chronic pancreatitis or pancreas cancer
  • Chronic glucocorticoid usage
  • Significant coronary artery disease or cerebrovascular disease within the previous 3 months
  • Uncompensated congestive heart failure
  • Severe pulmonary disease defined as FEV1 < 50% of predicted value
  • End stage renal disease on dialysis
  • Acute infectious disease within the previous 3 months
  • Pulmonary thromboembolism or thrombophlebitis within the previous 3 months
  • History of cancer (except for basal cell skin cancer or cancer in situ)
  • Prior gastrointestinal surgery (except for appendectomy or hemorrhoidectomy)
  • Gastrointestinal disorders, malabsorptive disorders, or inflammatory bowel disease
  • History of chronic liver disease (except for NAFLD/NASH)
  • Psychiatric disorders including dementia, active psychosis, severe depression requiring > 2 medications, history of suicide attempts, alcohol or drug abuse within the previous 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821961


Contacts
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Contact: Yeongkeun Kwon, MD, PhD +82 2 920 5027 kukwon@korea.ac.kr

Locations
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Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Yeongkeun Kwon, MD, PhD    +82 2 920 5027    kukwon@korea.ac.kr   
Sponsors and Collaborators
Korea University Anam Hospital
Myungmoon Pharma. Co. Ltd.
Investigators
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Principal Investigator: Sungsoo Park, MD, PhD Korea University Anam Hospital
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Responsible Party: Sungsoo Park, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT03821961    
Other Study ID Numbers: STARDOM-PET
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sungsoo Park, Korea University Anam Hospital:
Diabetes Mellitus, Type 2
PreDiabetes
Obesity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia