Insulin Resistance in Stress-metabolic Medical Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- C-peptide
研究概览
简要总结
An observational study on the insulin resistance in sepsis and septic shock patients.
详细描述
This observational study is inspired by the short-term insulin resistance and hyperglycemia that have been demonstrated in post-operative patients in response to tissue injury by Van den Berghe et al 2001. This short-term insulin resistance and hyperglycemia have also been observed in acutely ill patients (Van den Berghe et al 2006). The underlying mechanism for why acute ill patients have short-term insulin resistance is still unclear, but it is believed that the basic mechanism is increased glucose regeneration and gluconeogenesis, which is the consequence of stress metabolism. Hyperglycemia can occur as a result of insulin resistance and is associated with an increased risk of multiple complications, which is why it is important to detect and treat (Van den Berghe et al 2001). This also means that the more insulin-resistant the patient has been prior to the acute condition, the greater the risk of elevated blood glucose concentrations. PRS Review Comments identify apparent errors, deficiencies, or inconsistencies in the submitted information. Any comments provided should not be considered comprehensive. Advisory comments noted in a previous version of a study record may apply to subsequent versions, even if not repeated. It is the responsibility of the data provider to ensure that the record is consistent with the ClinicalTrials.gov Review Criteria.
The aim of the study is to clarify the degree of insulin resistance in medical patients who are not diagnosed with diabetes. Further it will be clarified how long these patients remain insulin resistant after discharge.
The acute medical patients diagnosed with sepsis or septic shock will be observed during hospitalization and after discharge. Sepsis is defined as life-threatening organ dysfunction caused by dysregulated host response to infection. Because the entire body is affected by an infection, it is expected that this group of patients have a high level of stress metabolism, insulin resistance and increased gluconeogenesis. The hypothesis is that acute medical patients diagnosed with sepsis or septic shock have a level of insulin resistance (days to weeks) and thus an increased risk of hyperglycemia. Insulin resistance is expected to decrease as the patient's condition improves.
The hypothesis is:
Patients with elevated infection levels (CRP and leukocyte count) who are simultaneously diagnosed with sepsis, has peripheral insulin resistance due to stress metabolism.
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
- •Patients with sepsis or septic shock who are admitted to the emergency ward and subsequently transferred to an intensive, intermediate or medical ward at Slagelse Hospital. Patients are diagnosed with sepsis or septic shock based on screening using Sequential (sepsis-related) Organ Failure Assessment (SOFA) or Quick SOFA (qSOFA).
- •Patients must be of legal age.
排除标准
- •Patients with diabetes (T1DM or T2DM)
- •Patients with terminal cancer
- •Patients who are already participating in a trial
- •Patients who do not understand and speak danish
- •Patients who are demented
- •Postoperative patients <1 month after surgery
- •Patients who are going through dialysis
结局指标
主要结局
C-peptide
时间窗: 28 days
Changes in C-peptide over time
次要结局
- Correlation between infection rate and insulin resistance.(28 days)
- Infection level and C-peptide concentration(28 days)
- Blood glucose level(28 days)
