Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001346763
Ethics application status
Approved
Date submitted
5/12/2013
Date registered
9/12/2013
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the rate of undiagnosed type 2 diabetes in patients referred for angiograms
Scientific title
A prospective observational study in sequential patients referred for outpatient coronary angiograms to assess rates of undiagnosed dysglycaemia
Secondary ID [1] 283700 0
nil
Universal Trial Number (UTN)
U1111-1151-0452
Trial acronym
ERUPT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 290660 0
dysglycaemia 290661 0
Condition category
Condition code
Metabolic and Endocrine 291040 291040 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective cross-sectional observational study. Consecutive patients presenting for outpatient angiograms will have a single blood test on the day of the angiogram.
Intervention code [1] 288395 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291025 0
rate of undiagnosed dysglycaemia by HbA1c serum assay
Timepoint [1] 291025 0
at screening
Primary outcome [2] 291026 0
renal function as measured by eGFR
Timepoint [2] 291026 0
at screening
Secondary outcome [1] 305860 0
To assess relationship between serum HbA1c levels and eGFR
To assess relationship between HbA1c and degree of coronary artery assessed by angiogram
To assess relationship between eGFR and degree of coronary artery disease assessed by agiogram
Timepoint [1] 305860 0
at screening

Eligibility
Key inclusion criteria
Adults seen for outpatient coronary angiogram at Auckland City Hospital.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Based on expected rate of 20% undiagnosed diabetes, 1000 patients will enter this study.
Absolute levels of patients with dysglycaemia will be reported. Levels of previously unknown dysglycaemia will be reported.
Relations between HbA1c levels and eGFR will be performed, HbA1c and degree of coronary artery, eGFR and degree of coronary artery disease will be assessed by analysis of (co) variance

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
13/01/2014
Actual
26/01/2015
Date of last participant enrolment
Anticipated
14/07/2014
Actual
1/02/2016
Date of last data collection
Anticipated
Actual
29/02/2016
Sample size
Target
1000
Accrual to date
Final
300
Recruitment outside Australia
Country [1] 5665 0
New Zealand
State/province [1] 5665 0

Funding & Sponsors
Funding source category [1] 288384 0
Charities/Societies/Foundations
Name [1] 288384 0
A+ charity trust
Country [1] 288384 0
New Zealand
Primary sponsor type
Hospital
Name
Cardiology Department, Auckland City Hospital
Address
Cardiology Dept, Auckland City Hospital
Park Rd, Grafton,
Auckland1030
Country
New Zealand
Secondary sponsor category [1] 287084 0
None
Name [1] 287084 0
Address [1] 287084 0
Country [1] 287084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290268 0
Northern A Health and Disability Ethics Committe
Ethics committee address [1] 290268 0
Ethics committee country [1] 290268 0
New Zealand
Date submitted for ethics approval [1] 290268 0
06/12/2013
Approval date [1] 290268 0
06/02/2014
Ethics approval number [1] 290268 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44750 0
Dr Jocelyne Rachelle Benatar
Address 44750 0
Cardiology, Level 3
Auckland City Hospital
Park Rd
Grafton
Auckland
1030
Country 44750 0
New Zealand
Phone 44750 0
+6493074949
Fax 44750 0
Email 44750 0
[email protected]
Contact person for public queries
Name 44751 0
Jocelyne Rachelle Benatar
Address 44751 0
Cardiology, Level 3
Auckland City Hospital
Park Rd
Grafton
Auckland
1030
Country 44751 0
New Zealand
Phone 44751 0
+6493074949
Fax 44751 0
Email 44751 0
[email protected]
Contact person for scientific queries
Name 44752 0
Jocelyne Rachelle Benatar
Address 44752 0
Cardiology, Level 3
Auckland City Hospital
Park Rd
Grafton
Auckland
1030
Country 44752 0
New Zealand
Phone 44752 0
+6493074949
Fax 44752 0
Email 44752 0
[email protected]

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.