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Status unknownNCT03821961Updated Feb 26, 2020

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

An interventional study of Metabolic Surgery in Diabetes Mellitus, Type 2, PreDiabetes and Obesity, sponsored by Korea University Anam Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by Korea University Anam Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2018, registered Jan 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Diabetes Mellitus, Type 2
  • PreDiabetes
  • Obesity

Keywords

  • Diabetes Mellitus, Type 2
  • PreDiabetes
  • Obesity
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 30 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Korea University Anam Hospital is the lead sponsor of 110 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Metabolic surgery

    Roux-en-Y gastric bypass, Sleeve gastrectomy

    Procedure: Metabolic Surgery

Interventions

  • ProcedureMetabolic Surgery

    Roux-en-Y gastric bypass, Sleeve gastrectomy

06

What researchers measure

Primary outcomes

  1. Change in Uptake value of 18F-FDOPA PET/CT from baseline

    Standardized Uptake Value

    Time frame: 6 months

Secondary outcomes

  1. Change in Glycated Hemoglobin from baseline

    percent change

    Time frame: 6 months

  2. Change in Fasting Plasma Glucose from baseline

    percent change

    Time frame: 6 months

  3. Changes in c-peptide level from baseline

    percent change

    Time frame: 6 months

  4. Changes in Insulinogenic index from baseline

    (insulin30 min - insulinfasting)/(glucose30 min - glucosefasting)

    Time frame: 6 months

  5. Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline

    (insulinfasting × glucosefasting)/405

    Time frame: 6 months

  6. Changes in Matsuda index from baseline

    Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)

    Time frame: 6 months

  7. Change in Body Mass Index (BMI) from baseline

    percent change

    Time frame: 6 months

  8. Change in Systolic Blood Pressure from baseline

    percent change

    Time frame: 6 months

  9. Change in serum level of HDL cholesterol from baseline

    percent change

    Time frame: 6 months

  10. Change in serum level of Triglycerides from baseline

    percent change

    Time frame: 6 months

  11. Change in serum level of LDL cholesterol from baseline

    percent change

    Time frame: 6 months

  12. Change in serum level of Total Cholesterol from baseline

    percent change

    Time frame: 6 months

  13. Change in serum level of High-sensitivity C-reactive Protein

    percent change

    Time frame: 6 months

  14. Change in number of diabetes medication from baseline

    number of medication

    Time frame: 6 months

  15. Change in dosage of diabetes medication from baseline

    Dosage of medication

    Time frame: 6 months

  16. Change in number of hypertension medication from baseline

    number of medication

    Time frame: 6 months

  17. Change in dosage of hypertension medication from baseline

    Dosage of medication

    Time frame: 6 months

  18. Change in number of dyslipidemia medication from baseline

    number of medication

    Time frame: 6 months

  19. Change in dosage of dyslipidemia medication from baseline

    Dosage of medication

    Time frame: 6 months

  20. Change in serum level of amino acid metabolites from baseline

    glucose homeostasis and energy expenditure related metabolites

    Time frame: 6 months

  21. Change in BDI scores of questionnaire from baseline

    Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)

    Time frame: 6 months

  22. Change in HDRS scores of questionnaire from baseline

    Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)

    Time frame: 6 months

  23. Change in SF-36 scores of questionnaire from baseline

    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)

    Time frame: 6 months

  24. Change in IWQOL scores of questionnaire from baseline

    Impact of Weight on Quality of Life(Score range, 31-155)(Higer values represent a worse outcome)

    Time frame: 6 months

  25. Change in MAQOL scores of questionnaire from baseline

    Moorehead-Ardelt Quality of Life(Score range, -3 to 3)(Higer values represent a better outcome)

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Korea University Anam Hospital
    Seoul, 02841, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03821961
Lead sponsor
Korea University Anam Hospital
Collaborators
Myungmoon Pharma. Co. Ltd.
Responsible party
Sungsoo Park (Professor, Korea University Anam Hospital) — Principal investigator
First posted
Jan 30, 2019
Start date
Sep 3, 2018
Primary completion
Nov 30, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Feb 26, 2020

Study contacts

Yeongkeun Kwon, MD, PhD
Contact
kukwon@korea.ac.kr
+82 2 920 5027
Sungsoo Park, MD, PhD
principal investigator · Korea University Anam Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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