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Gene hunt aims to predict deadly diabetes drug complication

NCT ID NCT05402579

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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