NCT01922492Unknown不适用
Effect of Islet Autotransplantation Compared to Oral Antidiabetic Drug in Partially Pancreatectomized Patients Due to Benign Pancreatic Neoplasm.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Changes of insulin secretory function
研究概览
简要总结
- Effects of autologous islet transplantation were compared to those of oral anti-diabetic drugs after distal pancreatectomy.
- The primary interest is a insulin-secretory function after the surgery in two intervention groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent distal pancreatectomy for pathologic diagnosis of pancreatic mass
排除标准
- •Prior history of diabetes mellitus
- •Patients whose fasting, post-load (75g OGTT) glucose or HbA1c level meet ADA diagnostic criteria
- •Patients who refused to participate the study
研究组 & 干预措施
Autologous islet transplantation
Experimental
Autologous islet transplantation arm: autologous islet transplantation
干预措施: Autologous islet transplantation (Procedure)
Oral anti-diabetic drugs
Active Comparator
Metformin (starting from 500mg qd with dose adjustment thereafter) with or without vildagliptin (starting from 50mg qd with dose adjustment thereafter)
干预措施: Oral anti-diabetic drugs (Drug)
结局指标
主要结局
Changes of insulin secretory function
时间窗: preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.
Insulin secretion was evaluated by calculating insulinogenic index (Δ insulin30min (μIU/ml)/Δglucose30min (mmol/L) during 75g-OGTT) and homeostasis model assessment for beta cell function (HOMA-B).
次要结局
- Changes of insulin resistance(preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.)
- Changes of glucose tolerance(preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.)
- Incidence of postoperative diabetes mellitus(preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.)
- Adverse effects(preop., 1 week and 1 month postop., and every 3 months after the surgery until 5 year postop.)
研究者
Kyong Soo Park
Professor
Seoul National University Hospital
研究点 (1)
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