Clinical trial NCT03821961: 18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery
Official title: The Effect of Metabolic Surgery on the Endocrine Function of Pancreas: Clinical Value of 18F-FDOPA PET/CT Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
PreDiabetes
Obesity
Keywords: Diabetes Mellitus, Type 2
PreDiabetes
Obesity
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Myungmoon Pharma. Co. Ltd.
First posted: 2019-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in Uptake value of 18F-FDOPA PET/CT from baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change in Glycated Hemoglobin from baseline
timeFrame: 6 months
measure: Change in Fasting Plasma Glucose from baseline
timeFrame: 6 months
measure: Changes in c-peptide level from baseline
timeFrame: 6 months
measure: Changes in Insulinogenic index from baseline
timeFrame: 6 months
measure: Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline
timeFrame: 6 months
measure: Changes in Matsuda index from baseline
timeFrame: 6 months
measure: Change in Body Mass Index (BMI) from baseline
timeFrame: 6 months
measure: Change in Systolic Blood Pressure from baseline
timeFrame: 6 months
measure: Change in serum level of HDL cholesterol from baseline
timeFrame: 6 months
measure: Change in serum level of Triglycerides from baseline
timeFrame: 6 months
measure: Change in serum level of LDL cholesterol from baseline
timeFrame: 6 months
measure: Change in serum level of Total Cholesterol from baseline
timeFrame: 6 months
measure: Change in serum level of High-sensitivity C-reactive Protein
timeFrame: 6 months
measure: Change in number of diabetes medication from baseline
timeFrame: 6 months
measure: Change in dosage of diabetes medication from baseline
timeFrame: 6 months
measure: Change in number of hypertension medication from baseline
timeFrame: 6 months
measure: Change in dosage of hypertension medication from baseline
timeFrame: 6 months
measure: Change in number of dyslipidemia medication from baseline
timeFrame: 6 months
measure: Change in dosage of dyslipidemia medication from baseline
timeFrame: 6 months
measure: Change in serum level of amino acid metabolites from baseline
timeFrame: 6 months
measure: Change in BDI scores of questionnaire from baseline
timeFrame: 6 months
measure: Change in HDRS scores of questionnaire from baseline
timeFrame: 6 months
measure: Change in SF-36 scores of questionnaire from baseline
timeFrame: 6 months
measure: Change in IWQOL scores of questionnaire from baseline
timeFrame: 6 months
measure: Change in MAQOL scores of questionnaire from baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Sungsoo Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: