Obesity Clinical Trial
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
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Anam Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Anam Hospital | Myungmoon Pharma. Co. Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Uptake value of 18F-FDOPA PET/CT from baseline | Standardized Uptake Value | 6 months | |
Secondary | Change in Glycated Hemoglobin from baseline | percent change | 6 months | |
Secondary | Change in Fasting Plasma Glucose from baseline | percent change | 6 months | |
Secondary | Changes in c-peptide level from baseline | percent change | 6 months | |
Secondary | Changes in Insulinogenic index from baseline | (insulin30 min - insulinfasting)/(glucose30 min - glucosefasting) | 6 months | |
Secondary | Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline | (insulinfasting × glucosefasting)/405 | 6 months | |
Secondary | Changes in Matsuda index from baseline | Insulin sensitivity indices obtained from oral glucose tolerance testing (Diabetes Care 22:1462-1470, 1999) | 6 months | |
Secondary | Change in Body Mass Index (BMI) from baseline | percent change | 6 months | |
Secondary | Change in Systolic Blood Pressure from baseline | percent change | 6 months | |
Secondary | Change in serum level of HDL cholesterol from baseline | percent change | 6 months | |
Secondary | Change in serum level of Triglycerides from baseline | percent change | 6 months | |
Secondary | Change in serum level of LDL cholesterol from baseline | percent change | 6 months | |
Secondary | Change in serum level of Total Cholesterol from baseline | percent change | 6 months | |
Secondary | Change in serum level of High-sensitivity C-reactive Protein | percent change | 6 months | |
Secondary | Change in number of diabetes medication from baseline | number of medication | 6 months | |
Secondary | Change in dosage of diabetes medication from baseline | Dosage of medication | 6 months | |
Secondary | Change in number of hypertension medication from baseline | number of medication | 6 months | |
Secondary | Change in dosage of hypertension medication from baseline | Dosage of medication | 6 months | |
Secondary | Change in number of dyslipidemia medication from baseline | number of medication | 6 months | |
Secondary | Change in dosage of dyslipidemia medication from baseline | Dosage of medication | 6 months | |
Secondary | Change in serum level of amino acid metabolites from baseline | glucose homeostasis and energy expenditure related metabolites | 6 months | |
Secondary | Change in BDI scores of questionnaire from baseline | Beck Depression Inventory(Score range, 0-68)(Higer values represent a worse outcome) | 6 months | |
Secondary | Change in HDRS scores of questionnaire from baseline | Hamilton Depression Rating Scale(Score range, 0-54)(Higer values represent a worse outcome) | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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