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

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetes Mellitus, Type 2, PreDiabetes, Obesity

Intervention / Treatment
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* Procedure: Metabolic Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metabolic surgery<br>Roux-en-Y gastric bypass, Sleeve gastrectomy | Procedure: Metabolic Surgery<br>* Roux-en-Y gastric bypass, Sleeve gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Uptake value of 18F-FDOPA PET/CT from baseline | Standardized Uptake Value | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, PreDiabetes, Obesity