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| Name | Class |
|---|---|
| Myungmoon Pharma. Co. Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metabolic surgery | Experimental | Roux-en-Y gastric bypass, Sleeve gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metabolic Surgery | Procedure | Roux-en-Y gastric bypass, Sleeve gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Uptake value of 18F-FDOPA PET/CT from baseline | Standardized Uptake Value | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Hemoglobin from baseline | percent change | 6 months |
| Change in Fasting Plasma Glucose from baseline | percent change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeongkeun Kwon, MD, PhD | Contact | +82 2 920 5027 | kukwon@korea.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sungsoo Park, MD, PhD | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |