Gene hunt aims to predict deadly diabetes drug complication
NCT ID NCT05402579
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a person's genes can help predict their risk of diabetic ketoacidosis (DKA) when taking SGLT2 inhibitors, a common class of diabetes drugs. Researchers collected DNA from 63 adults with type 2 diabetes who were either hospitalized with DKA while on the drug or were taking it without DKA. The goal was to find genetic variants that might explain why some people develop this life-threatening side effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- genomic analysis
- What this could lead to
- If successful, this could help doctors identify who is at higher risk of diabetic ketoacidosis when taking SGLT2 inhibitors, making the drugs safer to use.
- What could go wrong
- This was a small, completed study with only 63 participants. The findings are exploratory and may not lead to a usable test without much larger validation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
63 people
The number who actually took part.
- Started
-
Jul 2022
- Finished
-
Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Cases: Patients with type 2 diabetes mellitus who were hospitalized with SGLT2 inhibitor-associated DKA will be eligible for inclusion in our study. Controls: There are two sources for controls. \[1\] Patients hospitalized at one of the participating hospitals who were on an SGLT2i and do not have DKA. \[2\] Population controls using publicly available data from the Canadian Longitudinal Study on Aging (CLSA) database.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Diabetes type 2 are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
St. Joseph's Health Centre (Unity Health Toronto)
Toronto, Ontario, Canada
-
Toronto General Hospital (University Health Network)
Toronto, Ontario, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can six weeks of leg presses recharge aging muscles?
- A routine blood count may reveal how severe diabetic ketoacidosis will be
- A finger pulse reading may reveal how dangerous diabetic ketoacidosis is
- Diabetes Care's hidden hurdle: can patients understand the advice?
- Should DKA patients fast or feast? trial tests early eating in the ICU
- Can we predict kidney damage in young diabetics before it starts?