Diabetes Mellitus After Intensive Care Admission

NCT02180555 | Unknown

• 2 other identifiers: EC 12/2/22B300201213039
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Hyperglycemia; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient characteristics predicting adverse outcome

  6-9 months after ICU discharge

Study Arms (1)

ICU patients

Other: Oral glucose tolerance test

Interventions

Oral glucose tolerance test OTHER

ICU patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christophe De Block: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Related Publications (2)

• 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.

  PMID: 20615210 BACKGROUND

• 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.

  PMID: 26428846 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Central Study Contacts

Philippe G Jorens, MD, PhD

CONTACT

00323821; philippe.jorens@uza.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: February 1, 2012
• Primary Completion: July 1, 2015
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

BE (1)