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Investigating Metabolic Acidosis in Gastroenterology Induced by Colonoscopy preparation and Sodium glucose transporter 2 inhibitors: The MAGICS Study

Investigating Metabolic Acidosis in Gastroenterology Induced by Colonoscopy preparation and Sodium glucose transporter 2 inhibitors: The MAGICS Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622000896774
Acronym
MAGICS
Enrollment
200
Registered
2022-06-23
Start date
2022-10-20
Completion date
2024-08-28
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Metro South Health Research Support Scheme (MSH RSS)
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026