Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000449639
Ethics application status
Approved
Date submitted
16/04/2014
Date registered
1/05/2014
Date last updated
4/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The significance of hyperglycaemia in survivors of critical illness and potential mechanisms underlying development of type 2 diabetes
Scientific title
The significance of hyperglycaemia in survivors of critical illness and potential mechanisms underlying development of type 2 diabetes
Secondary ID [1] 284453 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 291678 0
Type 2 Diabetes 291744 0
Hyperglycaemia 291745 0
Condition category
Condition code
Metabolic and Endocrine 292055 292055 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Blood test (HBA1c & Fasting Lipids), Oral Glucose tolerance test , Isotope breath test and height, weight and blood pressure will be measured at 3 months, 1, 2, 3, 6 and 10 years of health and unhealthy volunteers.
Intervention code [1] 289205 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291935 0
Development of Type 2 Diabetes (assessed by Oral Glucose tolerance test and HbA1c blood test)
Timepoint [1] 291935 0
3 months, 1,2,3,6,10 years post hospital discharge
Secondary outcome [1] 307862 0
Measurement of glucose intolerance via oral glucose tolerance test, HBA1c levels and fasting lipds
Timepoint [1] 307862 0
3 months, 1,2,3,6,10 years post hospital discharge

Eligibility
Key inclusion criteria
Critical Illness-associated hyperglycaemia: HbA1c < 6.5%, blood glucose concentrations > 11.1 mmol/l for at least two consecutive readings during ICU admission
Normoglycaemic: HbA1c < 6.5%, fasted blood glucose concentrations remain < 7.1mmol/l and random concentrations remain < 11.1 mmol/l throughout ICU admission
Healthy volunteers: >18 years of age, sex and BMI will be used to match volunteers
Minimum age
30 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent, current pregnancy, previous gestational diabetes, acute or chronic pancreatitis, medications known to affect glucose metabolism (e.g. steroids)

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Power calculations were completed

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2014
Actual
27/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2333 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8010 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289100 0
Government body
Name [1] 289100 0
NHMRC
Country [1] 289100 0
Australia
Primary sponsor type
Individual
Name
Dr Adam Deane
Address
ICU Research, Royal Adelaide Hospital
North Tce, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 287763 0
None
Name [1] 287763 0
NA
Address [1] 287763 0
NA
Country [1] 287763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290888 0
Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 290888 0
Royal Adelaide Hospital
North Terrace, Adelaide, 5000
South Australia
Ethics committee country [1] 290888 0
Australia
Date submitted for ethics approval [1] 290888 0
Approval date [1] 290888 0
03/03/2014
Ethics approval number [1] 290888 0
131217

Summary
Brief summary
Conditions of temporary glucose intolerance - such as gestational diabetes - identify people who are at risk from subsequently developing type 2 diabetes. This is important as the prompt diagnosis of glucose intolerance allows earlier treatment and a consequent reduction in complications associated with prolonged and untreated hyperglycaemia, dyslipidaemia and hypertension. The possibility that critical illness-associated hyperglycaemia (CIAH) could be a risk factor for subsequent type 2 diabetes has only been evaluated in one study. This study however has substantial limitations, which severely restrict interpretation of these data. If CIAH is a risk factor for development of type 2 diabetes, and the mechanisms underlying any glucose intolerance elucidated, survivors could be screened for diabetes and prompt appropriate therapy instituted.
Trial website
NA
Trial related presentations / publications
NA
Public notes
NA

Contacts
Principal investigator
Name 47786 0
Dr Palash Kar
Address 47786 0
Intensive Care Unit, Royal Adelaide Hospital
North Tce
Adelaide 5000
South Australia
Country 47786 0
Australia
Phone 47786 0
+6188222 2818
Fax 47786 0
Email 47786 0
p_kar@hotmail.com
Contact person for public queries
Name 47787 0
Palash Kar
Address 47787 0
Intensive Care Unit, Royal Adelaide Hospital
North Tce
Adelaide 5000
South Australia
Country 47787 0
Australia
Phone 47787 0
+6188222 2818
Fax 47787 0
Email 47787 0
p_kar@hotmail.com
Contact person for scientific queries
Name 47788 0
Palash Kar
Address 47788 0
Intensive Care Unit, Royal Adelaide Hospital
North Tce
Adelaide 5000
South Australia
Country 47788 0
Australia
Phone 47788 0
+6188222 2818
Fax 47788 0
Email 47788 0
p_kar@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.