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

Not Applicable

• Conditions: Obesity; Diabetes Mellitus, Type 2; PreDiabetes
• Interventions: Procedure: Metabolic Surgery

• Registration Number: NCT03821961
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-03
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-26
• Study First Posted: 2019-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-23
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metabolic surgery	Metabolic Surgery	Roux-en-Y gastric bypass, Sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
Change in Uptake value of 18F-FDOPA PET/CT from baseline	6 months	Standardized Uptake Value

Secondary Outcome Measures

Name	Time	Method
Changes in Matsuda index from baseline	6 months	Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999)
Change in serum level of HDL cholesterol from baseline	6 months	percent change
Change in serum level of Triglycerides from baseline	6 months	percent change
Change in Glycated Hemoglobin from baseline	6 months	percent change
Change in Fasting Plasma Glucose from baseline	6 months	percent change
Changes in c-peptide level from baseline	6 months	percent change
Changes in Insulinogenic index from baseline	6 months	(insulin30 min - insulinfasting)/(glucose30 min - glucosefasting)
Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline	6 months	(insulinfasting × glucosefasting)/405
Change in Body Mass Index (BMI) from baseline	6 months	percent change
Change in Systolic Blood Pressure from baseline	6 months	percent change
Change in serum level of High-sensitivity C-reactive Protein	6 months	percent change
Change in number of diabetes medication from baseline	6 months	number of medication
Change in dosage of diabetes medication from baseline	6 months	Dosage of medication
Change in number of hypertension medication from baseline	6 months	number of medication
Change in serum level of LDL cholesterol from baseline	6 months	percent change
Change in serum level of Total Cholesterol from baseline	6 months	percent change
Change in dosage of hypertension medication from baseline	6 months	Dosage of medication
Change in number of dyslipidemia medication from baseline	6 months	number of medication
Change in dosage of dyslipidemia medication from baseline	6 months	Dosage of medication
Change in serum level of amino acid metabolites from baseline	6 months	glucose homeostasis and energy expenditure related metabolites
Change in HDRS scores of questionnaire from baseline	6 months	Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome)
Change in SF-36 scores of questionnaire from baseline	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)
Change in BDI scores of questionnaire from baseline	6 months	Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome)
Change in IWQOL scores of questionnaire from baseline	6 months	Impact of Weight on Quality of Life(Score range, 31-155)(Higer values represent a worse outcome)
Change in MAQOL scores of questionnaire from baseline	6 months	Moorehead-Ardelt Quality of Life(Score range, -3 to 3)(Higer values represent a better outcome)

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of