Glucose Control in Severely Burned Patients: Mechanisms and Therapeutic Potential
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Perform oral glucose tolerance test
研究概览
简要总结
The central aim of this application is to determine whether improved outcomes with tight euglycemic control are due to insulin-specific responses. The investigators hypothesize that improving insulin resistance will lead to decreased inflammatory and hypermetabolic responses, as well as restored glucose metabolism, and so result in improved clinical outcome of severely burned patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 and 90 years of age
- •>20% TBSA
- •Admitted to the burn unit within 120 hours following burn
- •At least 1 surgical intervention necessary
排除标准
- •death upon admission
- •decision not to treat due to burn injury severity
- •presence of anoxic brain injury that is not expected to result in complete recovery
- •known history of AIDS, ARC, HIV, Hepatitis B-E
- •history of cancer within 5 years of malignancy currently under treatment
- •inability to obtain informed consent
- •previous or existing renal dysfunction, liver disease, or hepatic dysfunction
- •pre-existing type I diabetes mellitus
- •pregnancy
- •allergy to metformin
研究组 & 干预措施
Metformin
干预措施: Metformin (Drug)
Insulin
干预措施: Humulin R (Drug)
结局指标
主要结局
Perform oral glucose tolerance test
时间窗: assessed at discharge (1-4 months post admission depending on the severity of injury)
Standard fasting oral glucose tolerance test with an intake of 75 g of glucose. Subsequent measurements (in mg/dl) of glucose in blood, insulin and c-peptide will be conducted over 2 hours.
次要结局
- Measure concentrations of serum cytokines(weekly until discharge (1-4 months post admission depending on severity of injury))
- Record the episodes of sepsis(daily until discharge (1-4 months post admission depending on severity of injury))
- Record the episodes of Pneumonia(daily until discharge (1-4 months post admission depending on severity of injury))
研究者
Dr. Marc Jeschke
Principal Investigator
Sunnybrook Health Sciences Centre