NCT07617155尚未招募4 期
Effects of GLP-1 Agonists on Prevention of HTG-Induced Acute Pancreatitis Recurrence: Protocol for a Randomized Clinical Trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 396
- 试验地点
- 1
研究概览
简要总结
Hypertriglyceridemia-induced acute pancreatitis (HTG-AP) is associated with a high risk of recurrence despite standard lipid-lowering therapy and lifestyle modification. The goal of this clinical trial is to evaluate whether GLP-1 receptor agonist therapy can reduce the recurrence of HTG-AP in adults with a history of HTG-AP and hypertriglyceridemia.
The main questions this study aims to answer are:
- Whether GLP-1 receptor agonist therapy reduces the recurrence rate of HTG-AP.
- Whether GLP-1 receptor agonist therapy improves triglyceride control, body weight, and metabolic parameters.
- Whether GLP-1 receptor agonist therapy is safe and well tolerated in this patient population.
Researchers will compare GLP-1 receptor agonist therapy plus standard care with standard care alone to determine whether GLP-1 receptor agonist therapy provides additional benefit in preventing recurrent HTG-AP.
Participants will:
- Receive either GLP-1 receptor agonist therapy plus standard care or standard care alone.
- Undergo regular clinical follow-up visits and laboratory assessments.
- Receive monitoring of triglyceride levels, recurrence events, metabolic outcomes, and adverse events during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Previous diagnosis of index HTG-AP (defined as AP with serum TG >1000 mg/dL or a serum TG level of 500-1000 mg/dL accompanied by chylous serum)36-38
- •Having HTG as the exclusive cause of AP
- •Time from discharge of index HTG-AP to recruitment between 4 weeks to 3 months, without AP-related symptoms between discharge and recruitment
- •Expression of the willingness to comply with lifestyle modification during the study period.
- •Clinically stable at the time of inclusion
- •The ability to understand the trial and completing it, as evaluated by the investigators.
- •Patients who may get pregnant should ensure using contraceptives for 20 months after inclusion
排除标准
- •History of malignancy in past 5 years
- •History of hypothyroidism, nephrotic syndrome, Cushing's syndrome or AIDS
- •History of chronic pancreatitis or pancreatic neoplasm
- •History of severe cardiovascular and pulmonary diseases, such as heart failure, coronary heart disease and chronic obstructive pulmonary disease.
- •Severe renal deficiency (glomerular filtration rate < 30 ml/min)
- •Severe hepatic deficiency (Child-Pugh Class B or C)
- •Previous pancreatic surgery
- •Recurrent AP due to pancreatic diverticulum
- •Recurrent AP due to known genetic mutations (eg. CFTR)
- •Personal or family history of medullary thyroid carcinoma (MTC)
- •Current or prior diagnosis or suspected diagnosis of multiple endocrine neoplasia type 2 (MEN2)
- •Serious hypersensitivity reaction to semaglutide or any of the excipients in the investigational drug or placebo
- •Pregnancy
- •Breast-feeding
研究者
DONG WU
Professor of Gastroenterology
Peking Union Medical College Hospital
研究点 (1)
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