Trial to investigate the effect of SGLT-2 inhibitor in treating elevated blood glucose after acute abdominal surgery

Phase 1

• Conditions: Postoperative (stress) hyperglycemia in patients with no known diabetes after acute abdominal surgery; MedDRA version: 24.0Level: LLTClassification code 10042216Term: Stress induced hyperglycemiaSystem Organ Class: 100000004861; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2020-004614-35-DK
• Lead Sponsor: Ismail Gögenur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-24
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the safety and feasibility of treating postoperative hyperglycemia in patients with no history of diabetes after acute abdominal surgery. ;Secondary Objective: described above;Primary end point(s): The primary endpoint is percentage of time in range (time with blood glucose level between 3.9 and 7.8mmol/l);Timepoint(s) of evaluation of this end point: Study medication must be started within 48 hours after surgery. The endpoint is monitored for 10 days after starting the medication or until discharged, whichever comes first.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) variability of blood glucose, mean blood glucose and time with hyper/hypo glycemia<br>2) quality of recovery-15 questionnaire<br>3) immunological changes (stress response) after surgery;Timepoint(s) of evaluation of this end point: 1) monitored for 10 days after starting the medication or until discharged, whichever comes first.<br>2) every day while hospitalised up til 10 days of treatment<br>3) blood samples drawn at inclusion, on day four of treatment and when finishing treatment