A Prospective Cohort Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis Complicated With Exocrine Dysfunction After Pancreatic Enzyme Intervention
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The changes in glucose profile before and after pancreatic enzyme intervention
研究概览
简要总结
This study aims to investigate the impact of pancreatic exocrine insufficiency on the glucose profile and pancreatic and gastrointestinal endocrine hormones in patients with chronic pancreatitis through pancreatic enzyme intervention in a reverse manner.
The primary objective is to observe the changes in glucose profile following pancreatic enzyme intervention in patients with chronic pancreatitis complicated by exocrine insufficiency and normal glucose metabolism.
The secondary objective is to observe the changes in pancreatic endocrine and exocrine functions and gastrointestinal endocrine hormone levels following pancreatic enzyme intervention in patients with chronic pancreatitis complicated by exocrine insufficiency and normal glucose metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Male or female Chinese subjects aged 18 years or older;
- •Patients with a clear diagnosis of chronic pancreatitis;
- •Glycated hemoglobin (HbA1c) levels between 4% and 6%;
- •FE-1 < 100 µg/g.
排除标准
- •1. A history of diabetes or prediabetes, or preoperative glycated hemoglobin (HbA1c) ≥ 6.0% or fasting venous glucose ≥ 6.1 mmol/L;
- •Positive for islet-related antibodies;
- •Patients who are currently receiving or have previously received pancreatic enzyme replacement therapy (PERT);
- •Allergy to the components of PERT drugs;
- •Exocrine pancreatic insufficiency (EPI) caused by other reasons, such as post-gastrectomy or post-intestinal resection;
- •Undergoing pancreatic surgery other than endoscopic retrograde cholangiopancreatography (ERCP);
- •Renal disease of stage G3, G4, or G5;
- •Decompensated chronic liver disease;
- •Receiving glucocorticoid therapy;
- •Pregnant or breastfeeding women;
- •Patients with malignant tumors.
研究组 & 干预措施
Creon（Pancreatin Enteric-coated Capsules）
For newly diagnosed patients with chronic pancreatitis combined with exocrine insufficiency, administer the Creon capsules and take them regularly for 3 months.
干预措施: Creon（Pancreatin Enteric-coated Capsules） (Drug)
结局指标
主要结局
The changes in glucose profile before and after pancreatic enzyme intervention
时间窗: From enrollment to 3 months after pancreatic enzyme intervention
次要结局
- Measure the changes in pancreatic endocrine and exocrine functions and gastrointestinal endocrine hormone levels after pancreatic enzyme intervention.(From enrollment to 3 months after pancreatic enzyme intervention)
研究者
Tuo Li, MD
Deputy Director
Shanghai Changzheng Hospital