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Diabetes Mellitus, Type 2NCT03821961

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

A study testing Metabolic Surgery in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Korea University Anam Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2, PreDiabetes, Obesity
What is being tested?
Metabolic Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
3 Sep 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Yeongkeun Kwon, MD, PhD contact

+82 2 920 5027

kukwon@korea.ac.kr

South Korea1 site, 1 recruiting

  • Korea University Anam Hospital

    Seoul, 02841

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

    Recruiting

Other trials in South Korea

About this study

Official title: The Effect of Metabolic Surgery on the Endocrine Function of Pancreas: Clinical Value of 18F-FDOPA PET/CT Imaging

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

Being tested
Metabolic Surgery
Keywords
Diabetes Mellitus, Type 2, PreDiabetes, Obesity
Medical subject headings
Diabetes Mellitus, Type 2, Prediabetic State, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metabolic SurgeryProcedure or surgery

    Roux-en-Y gastric bypass, Sleeve gastrectomy

Study groups in NCT03821961
Study groupRoleWhat they receive
Metabolic surgeryExperimentalRoux-en-Y gastric bypass, Sleeve gastrectomy
Receives: Procedure: Metabolic Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Standardized Uptake Value

    Measured: 6 months

Secondary outcomes (25)

  1. Change in Glycated Hemoglobin from baseline

    percent change

    Measured: 6 months

  2. Change in Fasting Plasma Glucose from baseline

    percent change

    Measured: 6 months

  3. Changes in c-peptide level from baseline

    percent change

    Measured: 6 months

  4. Changes in Insulinogenic index from baseline

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

    Measured: 6 months

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

    (insulinfasting × glucosefasting)/405

    Measured: 6 months

  6. Changes in Matsuda index from baseline

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

    Measured: 6 months

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

    percent change

    Measured: 6 months

  8. Change in Systolic Blood Pressure from baseline

    percent change

    Measured: 6 months

  9. Change in serum level of HDL cholesterol from baseline

    percent change

    Measured: 6 months

  10. Change in serum level of Triglycerides from baseline

    percent change

    Measured: 6 months

  11. Change in serum level of LDL cholesterol from baseline

    percent change

    Measured: 6 months

  12. Change in serum level of Total Cholesterol from baseline

    percent change

    Measured: 6 months

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

    percent change

    Measured: 6 months

  14. Change in number of diabetes medication from baseline

    number of medication

    Measured: 6 months

  15. Change in dosage of diabetes medication from baseline

    Dosage of medication

    Measured: 6 months

  16. Change in number of hypertension medication from baseline

    number of medication

    Measured: 6 months

  17. Change in dosage of hypertension medication from baseline

    Dosage of medication

    Measured: 6 months

  18. Change in number of dyslipidemia medication from baseline

    number of medication

    Measured: 6 months

  19. Change in dosage of dyslipidemia medication from baseline

    Dosage of medication

    Measured: 6 months

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

    glucose homeostasis and energy expenditure related metabolites

    Measured: 6 months

  21. Change in BDI scores of questionnaire from baseline

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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start3 Sep 2018
  3. Primary completion30 Nov 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03821961
Sponsor's protocol ID
STARDOM-PET
Status last verified
Feb 2020
First submitted
22 Jan 2019
Last updated
26 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Metabolic Surgery in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by Korea University Anam Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yeongkeun Kwon, MD, PhD (+82 2 920 5027, kukwon@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Uptake value of 18F-FDOPA PET/CT from baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03821961.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.

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