CClinicalTrials.gg
Status unknownNCT05314725Updated Apr 6, 2022

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

A Phase 2 interventional study of SGLT2 inhibitor and Placebo in Postoperative Hyperglycemia and Stress Hyperglycemia, sponsored by Zealand University Hospital. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by Zealand University Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Postoperative Hyperglycemia
  • Stress Hyperglycemia

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Keywords

  • acute abdominal surgery
  • SGLT-2 inhibitor
03

In context

Hyperglycemia

699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.

This study's planned enrollment of 24 is below the median of 46 across 521 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    SGLT-2 inhibitor

    Drug: SGLT2 inhibitor

  • Placebo comparator
    placebo

    Drug: Placebo

Interventions

  • DrugSGLT2 inhibitor

    10 days of SGLT2 inhibitor after surgery

  • DrugPlacebo

    10 days of placebo after surgery

06

What researchers measure

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. mean glucose

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

  2. glucose variability

    standard deviation divided by the mean and standard deviation

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

  3. time with level 1 hypoglycemia

    blood glucose 3.0-3.9mmol/l

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

  4. time with level 2 hypoglycemia

    blood glucose less than 3mmol/l

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

  5. time with hyperglycemia

    blood glucose more than 10mmol/l

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

  6. Quality of recovery-15

    Questionnaire assessing the patient's own sense of recovery after surgery

    Time frame: every day while taking the study medication and on postoperative day 30

  7. Nanostring

    changes in up- and downregulation of genes

    Time frame: at inclusion, on day 4 of treatment and at end of treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05314725
Lead sponsor
Zealand University Hospital
Responsible party
Sponsor
First posted
Apr 6, 2022
Start date
Jun 1, 2022 (estimated)
Primary completion
May 1, 2023 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Apr 6, 2022

Study contacts

Emilie Palmgren Colov, MD
Contact
eco@regionsjaelland.dk
+45 61335122
Ismail Gögenur, Dr.med
Contact
igo@regionsjaelland.dk
+45 26336426
Emilie P Palmgren Colov
principal investigator · Zealand University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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