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Diabetes Mellitus After Intensive Care Admission (DIAFIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02180555
Recruitment Status : Unknown
Verified July 2014 by Christophe De Block, University Hospital, Antwerp.
Recruitment status was:  Recruiting
First Posted : July 2, 2014
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):
Christophe De Block, University Hospital, Antwerp

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.

Condition or disease Intervention/treatment
Stress Hyperglycemia Diabetes Mellitus Other: Oral glucose tolerance test

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence and Predisposing Factors for the Development of Glucose Metabolism Disturbances and Diabetes Mellitus After Intensive Care Admission
Study Start Date : February 2012
Estimated Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Group/Cohort Intervention/treatment
ICU patients Other: Oral glucose tolerance test

Primary Outcome Measures :
  1. Glucose metabolism disturbance [ Time Frame: 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 :
  1. Patient characteristics predicting adverse outcome [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients

Inclusion Criteria:

  • ≥ 18 years old)
  • admitted for 36 hours or longer to the ICU
  • still alive 6 months after ICU discharge

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02180555

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Contact: Philippe G Jorens, MD, PhD 00323821 ext 3635

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Antwerp University Hospital Recruiting
Edegem, Antwerpen, Belgium, 2650
Contact: Philippe G Jorens, MD, PhD    00323821 ext 3635      
Sub-Investigator: Walter Verbrugghe, MD         
Sub-Investigator: Tom Schepens, MD PhD         
Sub-Investigator: Karolien Janssens, MD         
Principal Investigator: Christophe De Block, MD, PhD         
Sub-Investigator: Sofie Van Ackerbroeck, MD         
Sub-Investigator: Philippe G Jorens, MD, PhD         
Sponsors and Collaborators
Christophe De Block

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Christophe De Block, MD, PhD, University Hospital, Antwerp Identifier: NCT02180555     History of Changes
Other Study ID Numbers: EC 12/2/22
B300201213039 ( Other Identifier: Belgisch registratienummer )
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases