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Trial registered on ANZCTR


Registration number
ACTRN12622000896774
Ethics application status
Approved
Date submitted
20/06/2022
Date registered
23/06/2022
Date last updated
26/05/2024
Date data sharing statement initially provided
23/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating Metabolic Acidosis in Gastroenterology Induced by Colonoscopy preparation and Sodium glucose transporter 2 inhibitors: The MAGICS Study
Scientific title
Investigating Metabolic Acidosis in Gastroenterology Induced by Colonoscopy preparation and Sodium glucose transporter 2 inhibitors: The MAGICS Study
Secondary ID [1] 307339 0
nil
Universal Trial Number (UTN)
U1111-1292-9745
Trial acronym
MAGICS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 326700 0
SGLT2i 326701 0
ketoacidosis 326703 0
colonoscopy procedure 326704 0
Condition category
Condition code
Metabolic and Endocrine 323947 323947 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. All patients presenting for colonoscopy will be approached for inclusion in the study, and those who are regularly (at least 2 weeks prior to day of procedure) prescribed sodium-glucose co-transporter 2 inhibitors (SGLT2i) will be enrolled for the SGLT2i stratified group of the study.

2. Patients will be investigated with blood glucose levels, ketones, and venous blood gas analysis. This will be done once only at the time of routine intravenous cannula insertion and will take up to 3 minutes for the whole process. Specifically, a drop of blood can be aspirated with a syringe attached to the hub of the cannula, or via finger pricking at the discretion of the attending clinician.

3. Patient enrolment will be stratified into those presenting with elevated ketones and currently taking dapagliflozin and/or empagliflozin, the two most common SGLT2i.
Intervention code [1] 323822 0
Not applicable
Comparator / control treatment
Patients without T2DM (baseline reference group)
Control group
Active

Outcomes
Primary outcome [1] 331749 0
The primary outcome from this investigation is to determine the incidence of ketoacidosis in patients undergoing elective colonoscopy, especially while appropriately withholding SGLT2i. Additionally, if pre-procedural ketosis is related to residual SGLT2i in the patient's plasma, despite the patient ceasing it prior to their operative day; or if is entirely unrelated to their SGLT2i prescription and instead related to starvation. This will be addressed by measuring the concentration levels of SGLT2i in patient blood samples, which will be collected on the day of procedure and prior to the start of the procedure.
Timepoint [1] 331749 0
Day of procedure
Secondary outcome [1] 411005 0
In the event of ketoacidosis: the following secondary outcomes will be assessed:
Firstly, cancellation or delays to colonoscopy procedure. This will be collected from the information recorded within the patient's electronic chart in hospital records.
Timepoint [1] 411005 0
day of procedure
Secondary outcome [2] 411006 0
Secondly, ketoacidosis requiring overnight admission. This will be collected from the information recorded within the patient's electronic chart in hospital records.
Timepoint [2] 411006 0
day after procedure
Secondary outcome [3] 411007 0
Lastly, days alive and at home at 30 days will be collected as a composite secondary outcome from the information recorded within the patient's electronic chart in hospital records.
Timepoint [3] 411007 0
30 days after procedure

Eligibility
Key inclusion criteria
• Age greater than or equal to 18 years old
• All patients undergoing elective colonoscopies in 2022 and until mid 2023 across participating Metro South Health facilities
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Delay or cancellation of procedure not related to SGLT2i
• Patients with T1DM
• Chronic renal failure as defined by an eGFR less than or equal to 45 ml/min
• Pregnancy or lactation

Study design
Purpose
Natural history
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The statistical analysis required to determine the difference between the two mean SGLT2i plasma levels will involve a two-sided t-test. Residual SGLT2i concentration is expected to be 1.5% (SD1.5%) at 72hrs (12.5-hour half-life). 25 patients per group will provide 90% power at an alpha level of 0.05 to detect a significant difference. Pearson’s R correlation co-efficient can also be used to determine if a relationship exists between severity of acidosis and residual SGLT2i drug level. A total of 100 patients will be enrolled for the assessment of residual SGLT2i levels, and 100 patients in the non-diabetic control group, with a total sample size of 200 patients. Statistical support will be provided through Metro South QFAB program.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/07/2022
Actual
20/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
160
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22589 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 22590 0
Logan Hospital - Meadowbrook
Recruitment hospital [3] 22591 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 37844 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 37846 0
4108 - Coopers Plains
Recruitment postcode(s) [3] 37845 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 311630 0
Government body
Name [1] 311630 0
Metro South Health Research Support Scheme (MSH RSS)
Country [1] 311630 0
Australia
Primary sponsor type
Government body
Name
Metro South Health Research Support Scheme (MSH RSS)
Address
Building 5 Garden City Office Park
2404 Logan Rd
Eight Mile Plains QLD 4113
Country
Australia
Secondary sponsor category [1] 313121 0
None
Name [1] 313121 0
Address [1] 313121 0
Country [1] 313121 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311087 0
Metro South Research Ethics
Ethics committee address [1] 311087 0
Level 7, Translational Research Institute Building
Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [1] 311087 0
Australia
Date submitted for ethics approval [1] 311087 0
24/03/2022
Approval date [1] 311087 0
14/04/2022
Ethics approval number [1] 311087 0
HREC/2022/QMS/84444

Summary
Brief summary
Diabetic ketoacidosis is a metabolic emergency of increased acidity of the blood resulting from a lack of insulin and an accumulation of ketones within the bloodstream. In this study, we will review a cohort of Type 2 Diabetes Mellitus (T2DM) patients regularly taking sodium-glucose co-transporter 2 inhibitors (SGLT2i) who prepare for colonoscopy with SGLT2i cessation, bowel preparation, and starvation across a 12-month period. From this cohort, we will measure pre-procedural serum SGLT2i levels in patients both presenting with ketosis, and without ketosis and to compare residual SGLT2i drug level between patients who are acidotic versus those who are not. We hypothesise that severe ketoacidosis will be due to insufficient clearance of SGLT2i prior to the procedure. Importantly, should we demonstrate a link between residual plasma SGLT2i levels and ketosis, it may suggest longer pre-procedural cessation periods are warranted and ultimately, will decrease morbidity and mortality associated with the admission of patients with diabetes, and the inconvenience of day-of-procedure delays or cancellations, and improved utilisation of healthcare resources.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119894 0
A/Prof Pal Sivalingam
Address 119894 0
Department of Anaesthesia, Division of Surgery
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba QLD 4102
Country 119894 0
Australia
Phone 119894 0
+61 418 793 209
Fax 119894 0
Email 119894 0
[email protected]
Contact person for public queries
Name 119895 0
Pal Sivalingam
Address 119895 0
Department of Anaesthesia, Division of Surgery
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba QLD 4102
Country 119895 0
Australia
Phone 119895 0
+61 418 793 209
Fax 119895 0
Email 119895 0
[email protected]
Contact person for scientific queries
Name 119896 0
Pal Sivalingam
Address 119896 0
Department of Anaesthesia, Division of Surgery
Princess Alexandra Hospital
199 Ipswich Road, Woolloongabba QLD 4102
Country 119896 0
Australia
Phone 119896 0
+61 418 793 209
Fax 119896 0
Email 119896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved by ethics committee.


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.