UnknownPhase 2

Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial

24 participantsStarted 2022-06-01

Plain-language summary

The aim of the study is to investigate the effect of an SGLT-2 inhibitor on postoperative hyperglycemia after acute abdominal surgery in patients without diabetes

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \- Admitted to the ward after acute abdominal surgery (ASAP patient at Slagelse Hospital, OMEGA patient at Zealand University Hospital) * At least two independent measurements of blood glucose above 7.7mmol/l within the first 48 hours after surgery * Age of 18 to 85 * Must be able to understand and sign informed content Exclusion Criteria: * Patients diagnosed with diabetes mellitus * Impaired kidney function (eGFR \< 45mL/min) * Severe liver disease (defined as transaminases above X 3 normal levels) * Acute pancreatitis within the last two months or a history of chronic pancreatitis * Participation in another pharmacological intervention trial * Predictable poor compliance (for instance mentally impaired) * Pregnancy or lactation (fertile women must have a negative serum or urine pregnancy test to participate) * Allergy to study medication

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

time in range

Timeframe: from inclusion until 10 days after (or when the patient leaves the hospital)

Trial details

NCT IDNCT05314725

SponsorZealand University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-01

Contact for this trial

Emilie Palmgren Colov, MD

+45 61335122 eco@regionsjaelland.dk

View on ClinicalTrials.gov More Postoperative Hyperglycemia trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.