Treatment With SGLT-2 Inhibitor for Postoperative Hypergl... | NCT05314725

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

NCT05314725

Sponsor

Zealand University Hospital

Status

Unknown status

Last Update Posted

Apr 6, 2022Actual

Enrollment

24Estimated

Phase

Phase 2

Conditions

Postoperative Hyperglycemia
Stress Hyperglycemia

Interventions

SGLT2 inhibitor
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Estimated

Primary Completion Date

May 1, 2023Estimated

Completion Date

Jun 1, 2023Estimated

First Submitted Date

Mar 29, 2022

First Submission Date that Met QC Criteria

Mar 29, 2022

First Posted Date

Apr 6, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2022

Last Update Posted Date

Apr 6, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SGLT-2 inhibitor	Experimental		Drug: SGLT2 inhibitor
placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SGLT2 inhibitor	Drug	10 days of SGLT2 inhibitor after surgery	SGLT-2 inhibitor

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emilie Palmgren Colov, MD	Contact	+45 61335122		eco@regionsjaelland.dk
Ismail Gögenur, Dr.med	Contact	+45 26336426		igo@regionsjaelland.dk

Overall Officials

Name	Affiliation	Role
Emilie P Palmgren Colov	Zealand University Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077203	Sodium-Glucose Transporter 2 Inhibitors

Ancestor Terms

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D007004	Hypoglycemic Agents

Browse Leaves

Not provided

Browse Branches

Not provided