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

Phase 2

• Conditions: Postoperative Hyperglycemia; Stress Hyperglycemia
• Interventions: Drug: SGLT2 inhibitor; Drug: Placebo

• Registration Number: NCT05314725
• Lead Sponsor: Zealand University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-04-06
• Last Update Posted: 2022-04-06
• Study Start: 2022-06-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGLT-2 inhibitor	SGLT2 inhibitor	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
time in range	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)

Secondary Outcome Measures

Name	Time	Method
time with level 1 hypoglycemia	from inclusion until 10 days after (or when the patient leaves the hospital)	blood glucose 3.0-3.9mmol/l
glucose variability	from inclusion until 10 days after (or when the patient leaves the hospital)	standard deviation divided by the mean and standard deviation
mean glucose	from inclusion until 10 days after (or when the patient leaves the hospital)
time with level 2 hypoglycemia	from inclusion until 10 days after (or when the patient leaves the hospital)	blood glucose less than 3mmol/l
time with hyperglycemia	from inclusion until 10 days after (or when the patient leaves the hospital)	blood glucose more than 10mmol/l
Quality of recovery-15	every day while taking the study medication and on postoperative day 30	Questionnaire assessing the patient's own sense of recovery after surgery
Nanostring	at inclusion, on day 4 of treatment and at end of treatment	changes in up- and downregulation of genes