Postoperative HyperglycemiaPhase 2NCT05314725
Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial
A Phase 2 study testing SGLT2 inhibitor in people with Postoperative Hyperglycemia and Stress Hyperglycemia, run by Zealand University Hospital.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Hyperglycemia, Stress Hyperglycemia
- What is being tested?
- SGLT2 inhibitor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Conditions
- Postoperative Hyperglycemia, Stress Hyperglycemia
- Being tested
- SGLT2 inhibitor, Placebo
- Keywords
- acute abdominal surgery, SGLT-2 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
10 days of SGLT2 inhibitor after surgery
PlaceboDrug
10 days of placebo after surgery
| Study group | Role | What they receive |
|---|---|---|
| SGLT-2 inhibitor | Experimental | Not described Receives: Drug: SGLT2 inhibitor |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
time in range
percentage of time in range defined as blood glucose between 3.9 and 7.8mmol/l. Blood glucose will be measures continuously while taking the study medication)
Measured: from inclusion until 10 days after (or when the patient leaves the hospital)
Secondary outcomes (7)
mean glucose
Measured: from inclusion until 10 days after (or when the patient leaves the hospital)
glucose variability
standard deviation divided by the mean and standard deviation
Measured: from inclusion until 10 days after (or when the patient leaves the hospital)
time with level 1 hypoglycemia
blood glucose 3.0-3.9mmol/l
Measured: from inclusion until 10 days after (or when the patient leaves the hospital)
time with level 2 hypoglycemia
blood glucose less than 3mmol/l
Measured: from inclusion until 10 days after (or when the patient leaves the hospital)
time with hyperglycemia
blood glucose more than 10mmol/l
Measured: from inclusion until 10 days after (or when the patient leaves the hospital)
Quality of recovery-15
Questionnaire assessing the patient's own sense of recovery after surgery
Measured: every day while taking the study medication and on postoperative day 30
Nanostring
changes in up- and downregulation of genes
Measured: at inclusion, on day 4 of treatment and at end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie P Palmgren Colov, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314725
- Sponsor's protocol ID
- REG-094-2021
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial
- ClinicalTrials.gov ID
- NCT05314725
- Acronym / sponsor ID
- REG-094-2021
- Conditions
- Postoperative Hyperglycemia, Stress Hyperglycemia
- Keywords
- acute abdominal surgery, SGLT-2 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT-2 inhibitor | Experimental | Drug: SGLT2 inhibitor |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - 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
Key exclusion criteria (8 listed)
- Patients diagnosed with diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitor10 days of SGLT2 inhibitor after surgery | Drug | SGLT-2 inhibitor |
| Placebo10 days of placebo after surgery | Drug | placebo |
Primary outcome
time in range
Time frame: from inclusion until 10 days after (or when the patient leaves the hospital)
percentage of time in range defined as blood glucose between 3.9 and 7.8mmol/l. Blood glucose will be measures continuously while taking the study medication)
7 secondary outcomes
mean glucose
Time frame: from inclusion until 10 days after (or when the patient leaves the hospital)
glucose variability
Time frame: from inclusion until 10 days after (or when the patient leaves the hospital)
time with level 1 hypoglycemia
Time frame: from inclusion until 10 days after (or when the patient leaves the hospital)
time with level 2 hypoglycemia
Time frame: from inclusion until 10 days after (or when the patient leaves the hospital)
time with hyperglycemia
Time frame: from inclusion until 10 days after (or when the patient leaves the hospital)
Quality of recovery-15
Time frame: every day while taking the study medication and on postoperative day 30
Nanostring
Time frame: at inclusion, on day 4 of treatment and at end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie P Palmgren Colov principal investigator
Zealand University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGLT2 inhibitor in people with Postoperative Hyperglycemia and Stress Hyperglycemia, run by Zealand University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie Palmgren Colov, MD (+45 61335122, eco@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time in range (time frame: from inclusion until 10 days after (or when the patient leaves the hospital)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.