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

Not Applicable

Recruiting

• Conditions: Diabetes; SGLT2i; ketoacidosis; colonoscopy procedure; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622000896774
• Lead Sponsor: Metro South Health Research Support Scheme (MSH RSS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-23
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>[ Day of procedure]

Secondary Outcome Measures

Name	Time	Method
In the event of ketoacidosis: the following secondary outcomes will be assessed:<br>Firstly, cancellation or delays to colonoscopy procedure. This will be collected from the information recorded within the patient's electronic chart in hospital records.[ day of procedure];Secondly, ketoacidosis requiring overnight admission. This will be collected from the information recorded within the patient's electronic chart in hospital records.[ day after procedure];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.[ 30 days after procedure]