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

Stress Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05314725
• Other study ID #: REG-094-2021
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: March 2022
• Source: Zealand University Hospital
• Contact: Emilie Palmgren Colov, MD
• Phone: +45 61335122
• Email: eco[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperglycemia
• Stress Hyperglycemia

Intervention

Drug:
• SGLT2 inhibitor
10 days of SGLT2 inhibitor after surgery
• Placebo
10 days of placebo after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Outcome

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