Assessing genomic risk for diabetic ketoacidosis in patients using SGLT2 inhibitors
Diabetic Ketoacidosis From New SGLT2i: Can Genomics Estimate Risk (DaNGER)
This study is testing if certain genetic factors can help identify people with type 2 diabetes who are using SGLT2 inhibitors and may be at risk for diabetic ketoacidosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT05402579 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the risk of diabetic ketoacidosis (DKA) in patients with type 2 diabetes mellitus who are using SGLT2 inhibitors. By analyzing genomic data, the study seeks to identify which patients are at the highest risk of developing DKA and those who may benefit the most from SGLT2 inhibitors without significant risk. Participants will include individuals admitted to the hospital either with DKA related to SGLT2 inhibitors or those on SGLT2 inhibitors without DKA. The findings could lead to more personalized treatment strategies for diabetes management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of type 2 diabetes mellitus who have either experienced DKA related to SGLT2 inhibitors or are using these medications without DKA.
Not a fit: Patients with type 1 diabetes mellitus or those who have recently altered their insulin regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at risk for DKA, allowing for safer use of SGLT2 inhibitors in diabetes treatment.
How similar studies have performed: While the approach of using genomic analysis to predict DKA risk in SGLT2 inhibitor users is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: To be considered eligible for participation in this study, a participant must meet each of the following criteria: 1. Be 18 years or older and have a diagnosis of type 2 diabetes mellitus. 2. Have been admitted to hospital with SGLT2 inhibitor-associated DKA (cases) or admitted to hospital on an SGLT2 inhibitor and not have DKA (controls). 3. Be able to provide written consent (or, if patient is unable, have a substitute decision maker \[SDM\] available). Exclusion Criteria: A participant will be ineligible for participation in this study if he or she satisfies any one or more of the following criteria: 1. Diagnosis of type 1 diabetes mellitus. 2. Unable to spit 10mL into a vial. 3. A first degree relative has already been recruited into the study. 4. Had an alcohol binge before admission 5. Had prolonged fasting (\>48 hours) prior to hospital admission 6. 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.
Where this trial is running
Toronto, Ontario and 1 other locations
- St. Joseph's Health Centre (Unity Health Toronto) — Toronto, Ontario, Canada (Recruiting)
- Toronto General Hospital (University Health Network) — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Michael Fralick, MD, PhD
- Email: mike.fralick@sinaihealth.ca
- Phone: 4165864800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.