Diabetes Mellitus After Intensive Care Admission
- Conditions
- Stress HyperglycemiaDiabetes Mellitus
- Interventions
- Other: Oral glucose tolerance test
- Registration Number
- NCT02180555
- Lead Sponsor
- Christophe De Block
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- ≥ 18 years old)
- admitted for 36 hours or longer to the ICU
- still alive 6 months after ICU discharge
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ICU patients Oral glucose tolerance test -
- Primary Outcome Measures
Name Time Method Glucose metabolism disturbance 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%.
- Secondary Outcome Measures
Name Time Method Patient characteristics predicting adverse outcome 6-9 months after ICU discharge We will assess the effect of the patient's length, weight, body mass index (BMI), reason for admission, preadmission home medication, treatment during admission (steroids, vasopressors, inotropics, mechanical ventilation, insulin, total parenteral nutrition (TPN), laboratory values including blood glucose and HbA1c on intensive care unit (ICU) admission on our primary outcome parameter. Moreover, we will take into account the Simplified Acute Physiology Score (SAPS-3) and the daily Sequential Organ Failure Assessment (SOFA) score as parameters for disease severity, together with vasopressor or inotropic therapy, mechanical ventilation and length of stay at the hospital and ICU. Furthermore, our patients will complete the Finnish Diabetes Risk Score (FINDRISC) questionnaire during their follow-up visit, and we will compare this result with the primary outcome parameter as well.
Trial Locations
- Locations (1)
Antwerp University Hospital
🇧🇪Edegem, Antwerpen, Belgium