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

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 Overview

• Status: Not yet recruiting
• Conditions: Stress Hyperglycemia; Postoperative Hyperglycemia
• Intervention / Treatment: Drug: SGLT2 inhibitor; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Emilie Palmgren Colov, MD; Phone Number: +45 61335122; Email: eco@regionsjaelland.dk
• Study Contact Backup: Name: Ismail Gögenur, Dr.med; Phone Number: +45 26336426; Email: igo@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: placebo	Drug: Placebo; 10 days of placebo after surgery
EXPERIMENTAL: SGLT-2 inhibitor	Drug: SGLT2 inhibitor; 10 days of SGLT2 inhibitor after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean glucose		from inclusion until 10 days after (or when the patient leaves the hospital)
glucose variability	standard deviation divided by the mean and standard deviation	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	from inclusion until 10 days after (or when the patient leaves the hospital)
time with level 2 hypoglycemia	blood glucose less than 3mmol/l	from inclusion until 10 days after (or when the patient leaves the hospital)
time with hyperglycemia	blood glucose more than 10mmol/l	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	every day while taking the study medication and on postoperative day 30
Nanostring	changes in up- and downregulation of genes	at inclusion, on day 4 of treatment and at end of treatment

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Emilie P Palmgren Colov, Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2022
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (ACTUAL): April 6, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: SGLT-2 inhibitor; acute abdominal surgery
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors
• Other Study ID Numbers: REG-094-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No