Incidence and Predisposing Factors for the Development of Glucose Metabolism Disturbances and Diabetes Mellitus After Intensive Care Admission
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Glucose metabolism disturbance
研究概览
简要总结
Stress hyperglycaemia is commonly observed during hospitalization in the intensive care unit (ICU) and has been shown to adversely influence outcome. It has been hypothesized that, when it occurs in previously non-diabetic patients, it reflects a latent disturbance of the glucose metabolism. Assessing the incidence of this phenomenon and identifying its risk factors could support prevention, detection and early treatment of impending diabetes mellitus type 2. We will perform a glucose tolerance test approximately 6-9 months post-ICU admission to screen for disorders of glucose metabolism. Furthermore, we examined characteristics that could have predicted the post-discharge disturbances: patient characteristics, parameters of disease severity and of glucose metabolism, as well as the FINDRISC (Finnish Diabetes Risc Score). We plan to enroll 400 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •≥ 18 years old)
- •admitted for 36 hours or longer to the ICU
- •still alive 6 months after ICU discharge
排除标准
- •known Diabetes Mellitus or any other glucose tolerance disturbance
- •an estimated short life expectancy
- •pregnancy
- •a history of transplantation or acute pancreatic disease
- •language barrier preventing a clear understanding of the informed consent
结局指标
主要结局
Glucose metabolism disturbance
时间窗: 6-9 months after ICU discharge
At a follow-up visit, patients will have their blood glucose levels sampled both after fasting and 2 hours after an oral glucose tolerance test (OGTT). HbA1c levels will be sampled once as well. Possible disturbances in glucose metabolism are the following: isolated impaired fasting glucose (IFG) = fasting plasma glucose (FPG) level of 100-125 mg/dl with the 2-h value after OGTT \<140 mg/dl. Isolated impaired glucose tolerance (IGT) = 2-h value after OGTT of 140-199 mg/dl with the fasting level \<100 mg/dl. Patients with combined characteristics of IFG and IGT fulfill both criteria (FPG = 100-125 mg/dl and 2-h value after OGTT = 140-199 mg/d). Diabetes mellitus is diagnosed when a patient has one of the following criteria: FPG more or equal to 126mg/dl, 2-h value after OGTT more or equal to 200 mg/dl, HbA1c more or equal to 6.5%.
次要结局
- Patient characteristics predicting adverse outcome(6-9 months after ICU discharge)
研究者
Christophe De Block
MD, PhD
University Hospital, Antwerp