NCT03821961Unknown不适用
The Effect of Metabolic Surgery on the Endocrine Function of Pancreas: Clinical Value of 18F-FDOPA PET/CT Imaging
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Uptake value of 18F-FDOPA PET/CT from baseline
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes or prediabetes
- •Body mass index >25.0 kg/m2
- •Written informed consent
排除标准
- •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
结局指标
主要结局
Change in Uptake value of 18F-FDOPA PET/CT from baseline
时间窗: 6 months
Standardized Uptake Value
次要结局
- Change in Glycated Hemoglobin from baseline(6 months)
- Changes in Matsuda index from baseline(6 months)
- Change in serum level of HDL cholesterol from baseline(6 months)
- Change in serum level of Triglycerides from baseline(6 months)
- Change in Fasting Plasma Glucose from baseline(6 months)
- Changes in c-peptide level from baseline(6 months)
- Changes in Insulinogenic index from baseline(6 months)
- Changes in HOMA-IR(homeostatic model assessment for insulin resistance) from baseline(6 months)
- Change in Body Mass Index (BMI) from baseline(6 months)
- Change in Systolic Blood Pressure from baseline(6 months)
- Change in serum level of High-sensitivity C-reactive Protein(6 months)
- Change in number of diabetes medication from baseline(6 months)
- Change in dosage of diabetes medication from baseline(6 months)
- Change in number of hypertension medication from baseline(6 months)
- Change in serum level of LDL cholesterol from baseline(6 months)
- Change in serum level of Total Cholesterol from baseline(6 months)
- Change in dosage of hypertension medication from baseline(6 months)
- Change in number of dyslipidemia medication from baseline(6 months)
- Change in dosage of dyslipidemia medication from baseline(6 months)
- Change in serum level of amino acid metabolites from baseline(6 months)
- Change in HDRS scores of questionnaire from baseline(6 months)
- Change in SF-36 scores of questionnaire from baseline(6 months)
- Change in BDI scores of questionnaire from baseline(6 months)
- Change in IWQOL scores of questionnaire from baseline(6 months)
- Change in MAQOL scores of questionnaire from baseline(6 months)
研究者
Sungsoo Park
Professor
Korea University Anam Hospital
研究点 (2)
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