Diabetes Mellitus After Intensive Care Admission (DIAFIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Antwerp
Sponsor:
Information provided by (Responsible Party):
Christophe De Block, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT02180555
First received: July 1, 2014
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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 Intervention
Stress Hyperglycemia
Diabetes Mellitus
Other: Oral glucose tolerance test

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Glucose metabolism disturbance [ Time Frame: 6-9 months after ICU discharge ] [ Designated as safety issue: No ]
    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:
  • Patient characteristics predicting adverse outcome [ Time Frame: 6-9 months after ICU discharge ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 400
Study Start Date: February 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ICU patients Other: Oral glucose tolerance test

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ICU patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02180555

Contacts
Contact: Philippe G Jorens, MD, PhD 00323821 ext 3635 philippe.jorens@uza.be

Locations
Belgium
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
  More Information

Publications:
Responsible Party: Christophe De Block, MD, PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT02180555     History of Changes
Other Study ID Numbers: EC 12/2/22, B300201213039
Study First Received: July 1, 2014
Last Updated: July 7, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on October 01, 2014