Administration of Metformin and Insulin to Pancreatic Cancer Related Diabetes Mellitus (Type 3c)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Blood glucose control rate
研究概览
简要总结
About 80% of patients with pancreatic adenocarcinoma have aberrant fasting blood glucose at the time of diagnosis. The consistent association between pancreatic cancer and diabetes mellitus has long been recognized and even been termed as "chicken and egg". Many reports have found that pancreatic cancer can result in diabetes, which is called type 3c diabetes. New-onset diabetes is commonly observed in pancreatic cancer patients and has been considered as a potential screening sign. Moreover, diabetes has been found as a predictor of poor outcome in pancreatic cancer.
Pancreatic cancer cells have a strong dependence on glucose and they are well-known for their sweet teeth. High glucose is associated with impaired immunologic reaction, intolerability to chemotherapy, radiotherapy and other major treatments, an increased risk of pancreatic surgery. Given the linkage between pancreatic cancer and diabetes or high blood glucose, a clinical trial is needed to validate the effect of metformin and insulin on regulating blood glucose in type 3c diabetes.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed content obtained prior to treatment
- •Age ≥ 18 years and ≤ 80 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Patients must have histologically confirmed pancreatic adenocarcinoma
- •History of diabetes mellitus, or newly diagnosed diabetes mellitus according to the American Diabetes Association criteria
- •The expected survival after surgery ≥ 3 months
排除标准
- •Active second primary malignancy or history of second primary malignancy
- •Patients who have received any form of anti-tumor therapy including surgery, chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
- •Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc
- •Pregnant or nursing women
- •Patients who are unwilling or unable to comply with study procedures
研究组 & 干预措施
Metformin or insulin treatment
干预措施: Metformin or insulin treatment (Drug)
结局指标
主要结局
Blood glucose control rate
时间窗: 1 week
Blood glucose control rate before and after anti-diabetic administration
次要结局
- HbA1C control rate(1 week)