Diabetes Mellitus After Intensive Care Admission (DIAFIC)

Incidence and Predisposing Factors for the Development of Glucose Metabolism Disturbances and Diabetes Mellitus After Intensive Care Admission

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus; Stress Hyperglycemia
• Intervention / Treatment: Other: Oral glucose tolerance test

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Recruiting
      • Antwerp University Hospital
      • Contact: Philippe G Jorens, MD, PhD; Phone Number: 3635 00323821
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose metabolism disturbance	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%.	6-9 months after ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient characteristics predicting adverse outcome	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.	6-9 months after ICU discharge

Collaborators and Investigators

• Sponsor: Christophe De Block

Publications and helpful links

General Publications

• Gornik I, Vujaklija-Brajkovic A, Renar IP, Gasparovic V. A prospective observational study of the relationship of critical illness associated hyperglycaemia in medical ICU patients and subsequent development of type 2 diabetes. Crit Care. 2010;14(4):R130. doi: 10.1186/cc9101. Epub 2010 Jul 8. Erratum In: Crit Care. 2010;14(5):444.
• Van Ackerbroeck S, Schepens T, Janssens K, Jorens PG, Verbrugghe W, Collet S, Van Hoof V, Van Gaal L, De Block C. Incidence and predisposing factors for the development of disturbed glucose metabolism and DIabetes mellitus AFter Intensive Care admission: the DIAFIC study. Crit Care. 2015 Oct 2;19:355. doi: 10.1186/s13054-015-1064-9.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus
• Other Study ID Numbers: EC 12/2/22; B300201213039 (Other Identifier: Belgisch registratienummer)