Back to resultsTreatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial
Primary Purpose
Postoperative Hyperglycemia, Stress Hyperglycemia
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SGLT2 inhibitor
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Hyperglycemia focused on measuring acute abdominal surgery, SGLT-2 inhibitor
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SGLT-2 inhibitor
placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
mean glucose
glucose variability
standard deviation divided by the mean and standard deviation
time with level 1 hypoglycemia
blood glucose 3.0-3.9mmol/l
time with level 2 hypoglycemia
blood glucose less than 3mmol/l
time with hyperglycemia
blood glucose more than 10mmol/l
Quality of recovery-15
Questionnaire assessing the patient's own sense of recovery after surgery
Nanostring
changes in up- and downregulation of genes
Full Information
NCT ID
NCT05314725
First Posted
March 29, 2022
Last Updated
March 29, 2022
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05314725
Brief Title
Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial
Official Title
Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hyperglycemia, Stress Hyperglycemia
Keywords
acute abdominal surgery, SGLT-2 inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SGLT-2 inhibitor
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SGLT2 inhibitor
Intervention Description
10 days of SGLT2 inhibitor after surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10 days of placebo after surgery
Primary Outcome Measure Information:
Title
time in range
Description
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)
Time Frame
from inclusion until 10 days after (or when the patient leaves the hospital)
Secondary Outcome Measure Information:
Title
mean glucose
Time Frame
from inclusion until 10 days after (or when the patient leaves the hospital)
Title
glucose variability
Description
standard deviation divided by the mean and standard deviation
Time Frame
from inclusion until 10 days after (or when the patient leaves the hospital)
Title
time with level 1 hypoglycemia
Description
blood glucose 3.0-3.9mmol/l
Time Frame
from inclusion until 10 days after (or when the patient leaves the hospital)
Title
time with level 2 hypoglycemia
Description
blood glucose less than 3mmol/l
Time Frame
from inclusion until 10 days after (or when the patient leaves the hospital)
Title
time with hyperglycemia
Description
blood glucose more than 10mmol/l
Time Frame
from inclusion until 10 days after (or when the patient leaves the hospital)
Title
Quality of recovery-15
Description
Questionnaire assessing the patient's own sense of recovery after surgery
Time Frame
every day while taking the study medication and on postoperative day 30
Title
Nanostring
Description
changes in up- and downregulation of genes
Time Frame
at inclusion, on day 4 of treatment and at end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie Palmgren Colov, MD
Phone
+45 61335122
Email
eco@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ismail Gögenur, Dr.med
Phone
+45 26336426
Email
igo@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie P Palmgren Colov
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment With SGLT-2 Inhibitor for Postoperative Hyperglycemia in Acute Abdominal Surgery - a Randomized Trial
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