Status:
COMPLETED
Diabetic Ketoacidosis From New SGLT2i: Can Genomics Estimate Risk
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Unity Health Toronto
University Health Network, Toronto
Conditions:
Diabetes Type 2
DKA
Eligibility:
All Genders
18-100 years
Brief Summary
Sodium glucose co-transporter 2 (SGLT2) inhibitors have revolutionized care for people living with type 2 diabetes mellitus (T2DM). They reduce a person's risk of heart failure, renal failure, myocard...
Eligibility Criteria
Inclusion
- To be considered eligible for participation in this study, a participant must meet each of the following criteria:
- Be 18 years or older and have a diagnosis of type 2 diabetes mellitus.
- Have been admitted to hospital with SGLT2 inhibitor-associated DKA (cases) or admitted to hospital on an SGLT2 inhibitor and not have DKA (controls).
- Be able to provide written consent (or, if patient is unable, have a substitute decision maker \[SDM\] available).
Exclusion
- A participant will be ineligible for participation in this study if he or she satisfies any one or more of the following criteria:
- Diagnosis of type 1 diabetes mellitus.
- Unable to spit 10mL into a vial.
- A first degree relative has already been recruited into the study.
- Had an alcohol binge before admission
- Had prolonged fasting (\>48 hours) prior to hospital admission
- Recently stopped their insulin (within the past 7 days prior to hospital admission)
- Our study will not include children or pregnant women because SGLT2 inhibitors are not approved for use in either patient population.
Key Trial Info
Start Date :
July 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 20 2025
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05402579
Start Date
July 29 2022
End Date
January 20 2025
Last Update
December 4 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Joseph's Health Centre (Unity Health Toronto)
Toronto, Ontario, Canada
2
Toronto General Hospital (University Health Network)
Toronto, Ontario, Canada