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

NCT05314725 | Unknown Phase 2 DMC

• 1 other identifier: REG-094-2021
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Conditions

Postoperative Hyperglycemia; Stress Hyperglycemia

Keywords

acute abdominal surgery; SGLT-2 inhibitor

Outcome Measures

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)

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

Secondary Outcomes (7)

• mean glucose

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

• glucose variability

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

• time with level 1 hypoglycemia

  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)

• time with hyperglycemia

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

Study Arms (2)

SGLT-2 inhibitor

EXPERIMENTAL

Drug: SGLT2 inhibitor

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SGLT2 inhibitor DRUG

10 days of SGLT2 inhibitor after surgery

SGLT-2 inhibitor

Placebo DRUG

10 days of placebo after surgery

placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Emilie P Palmgren Colov

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Palmgren Colov, MD

CONTACT

+45 61335122; eco@regionsjaelland.dk

Ismail Gögenur, Dr.med

CONTACT

+45 26336426; igo@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: June 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share