Stress HyperglycemiaDIAFICNCT02180555
Diabetes Mellitus After Intensive Care Admission
An observational study of Stress Hyperglycemia and Diabetes Mellitus, run by Christophe De Block at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Hyperglycemia, Diabetes Mellitus
- What is being tested?
- Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2012to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients
Who may be able to join
- ≥ 18 years old)
- admitted for 36 hours or longer to the ICU
- still alive 6 months after ICU discharge
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerpen, 2650
Philippe G Jorens, MD, PhD, 00323821 ext. 3635
Walter Verbrugghe, MD
About this study
Official title: 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.
- Conditions
- Stress Hyperglycemia, Diabetes Mellitus
- Being tested
- Oral glucose tolerance test
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testOther
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | Not described Receives: Other: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 6-9 months after ICU discharge
Secondary outcomes (1)
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.
Measured: 6-9 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startFeb 2012
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christophe De Block
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christophe De Block, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180555
- Sponsor's protocol ID
- EC 12/2/22
- Other IDs
- B300201213039
- Acronym
- DIAFIC
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
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.
PubMed 20615210Van 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.
PubMed 26428846
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Predisposing Factors for the Development of Glucose Metabolism Disturbances and Diabetes Mellitus After Intensive Care Admission
- ClinicalTrials.gov ID
- NCT02180555
- Acronym / sponsor ID
- DIAFIC / EC 12/2/22
- Conditions
- Stress Hyperglycemia, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Christophe De BlockUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2015 (estimated)
- First posted
- 2 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Other: Oral glucose tolerance test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (3 listed)
- ≥ 18 years old)
- admitted for 36 hours or longer to the ICU
- still alive 6 months after ICU discharge
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance test | Other | ICU patients |
Primary outcome
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%.
1 secondary outcome
Patient characteristics predicting adverse outcome
Time frame: 6-9 months after ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Background: PubMed 20615210Gornik 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.
- Derived from this study: PubMed 26428846Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Hyperglycemia and Diabetes Mellitus, run by Christophe De Block at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe G Jorens, MD, PhD (00323821 ext. 3635, philippe.jorens@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose metabolism disturbance (time frame: 6-9 months after ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02180555, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.