AnesthesiaMACSNCT07573930
Metabolic Control in Anesthesia and Surgery
An observational study of Anesthesia and Continuous Glucose Monitoring, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The goal of this observational study is to investigate how a standard dose of the drug dexamethasone affects blood sugar levels during and after non-cardiac surgery in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Continuous Glucose Monitoring, Hyperglycemia Steroid-induced
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Apr 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, surgical population where dexamethasone may be administered as part of anesthetic preparation of the patient for surgery.
Who may be able to join
- Adult patients (≥18 years) scheduled for elective non cardiac surgery
- Expected surgery duration >1 hour
- Administration of dexamethasone as part of standard anaesthetic regimen or planned by the responsible anaesthetist to enhance recovery or to limit risk of PONV.
- Ability to provide written informed consent
Who cannot join
- Not possible to obtain consent or permission
- Known allergy or adverse reaction to dexamethasone
- Type 1 diabetes (due to need for insulin titration)
- Active infection, sepsis, or immunosuppression
- Contraindications to continuous glucose monitoring (CGM)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Roskilde, 4000
Anne M Brinck, MSc Medicine, +4552119003, abrinc@regionsjaelland.dk
About this study
Official title: Deteriorated Metabolic Control in the Perioperative Period in Surgical Patients: What is the Impact of Anesthetic Preparation and Patient Frailty?
The goal of this observational study is to investigate how a standard dose of the drug dexamethasone affects blood sugar levels during and after non-cardiac surgery in adult patients.
The main questions it aims to answer are:
Read more
- How does dexamethasone influence blood sugar levels in patients undergoing non-cardiac surgery?
- Does continuous glucose monitoring (CGM) provide a more accurate estimate of blood sugar fluctuations compared to traditional time-specific finger-prick measurements?
Participants are scheduled to receive dexamethasone as part of standard anesthesia care and will undergo their planned surgery. As part of the study, a continuous glucose monitoring (CGM) device will be placed on their upper arm approximately 12 hours before surgery and will remain in place for up to 10 days after the operation. During this period, their blood sugar levels will be measured using both the CGM device and traditional finger-prick tests. CGM readings are blinded for both participants and clinicians. No additional treatments or changes to their standard care will be made as a result of their participation in the study.
The study will include 100 adult patients from the Department of Anesthesiology at Sjællands University Hospital, Roskilde.
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of hyperglycemia I
Peak glucose level
Measured: Up to 10 days postoperatively
Characterization of hyperglycemia II
Duration of hyperglycemia
Measured: Up to 10 days postoperatively
Secondary outcomes (2)
Correlation between pre- and postoperative glucose trajectories
How does baseline dysglyceamia (elevated FPG or HbA1C) correlates to intra- and postoperative hyperglycemia
Measured: Up to 10 days postoperatively
Subgroup analyses
Comparing diabetic vs. non-diabetic patients and patients with obesity (BMI ≥30) vs. non-obese (BMI <30), frail vs non-frail, fasting vs non fasting surgeries
Measured: Up to 10 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start23 Apr 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne M Brinck, Msc Medicine, Principal investigator, Zealand University Hospital, Roskilde, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573930
- Sponsor's protocol ID
- SJ-1121
- Acronym
- MACS
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deteriorated Metabolic Control in the Perioperative Period in Surgical Patients: What is the Impact of Anesthetic Preparation and Patient Frailty?
- ClinicalTrials.gov ID
- NCT07573930
- Acronym / sponsor ID
- MACS / SJ-1121
- Conditions
- Anesthesia, Continuous Glucose Monitoring, Hyperglycemia Steroid-induced, Hyperglycemia Stress, Surgical Procedure, Unspecified
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to investigate how a standard dose of the drug dexamethasone affects blood sugar levels during and after non-cardiac surgery in adult patients.
The main questions it aims to answer are:
- How does dexamethasone influence blood sugar levels in patients undergoing non-cardiac surgery?
- Does continuous glucose monitoring (CGM) provide a more accurate estimate of blood sugar fluctuations compared to traditional time-specific finger-prick measurements?
Participants are scheduled to receive dexamethasone as part of standard anesthesia care and will undergo their planned surgery. As part of the study, a continuous glucose monitoring (CGM) device will be placed on their upper arm approximately 12 hours before surgery and will remain in place for up to 10 days after the operation. During this period, their blood sugar levels will be measured using both the CGM device and traditional finger-prick tests. CGM readings are blinded for both participants and clinicians. No additional treatments or changes to their standard care will be made as a result of their participation in the study.
The study will include 100 adult patients from the Department of Anesthesiology at Sjællands University Hospital, Roskilde.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, surgical population where dexamethasone may be administered as part of anesthetic preparation of the patient for surgery.
Key inclusion criteria (4 listed)
- Adult patients (≥18 years) scheduled for elective non cardiac surgery
- Expected surgery duration >1 hour
- Administration of dexamethasone as part of standard anaesthetic regimen or planned by the responsible anaesthetist to enhance recovery or to limit risk of PONV.
- Ability to provide written informed consent
Key exclusion criteria (5 listed)
- Not possible to obtain consent or permission
- Known allergy or adverse reaction to dexamethasone
- Type 1 diabetes (due to need for insulin titration)
- Active infection, sepsis, or immunosuppression
- Contraindications to continuous glucose monitoring (CGM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of hyperglycemia I
Time frame: Up to 10 days postoperatively
Peak glucose level
Characterization of hyperglycemia II
Time frame: Up to 10 days postoperatively
Duration of hyperglycemia
2 secondary outcomes
Correlation between pre- and postoperative glucose trajectories
Time frame: Up to 10 days postoperatively
Subgroup analyses
Time frame: Up to 10 days postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne M Brinck, Msc Medicine principal investigator
Zealand University Hospital, Roskilde, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Continuous Glucose Monitoring, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne M Brinck, MSc Medicine (+4552119003, abrinc@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of hyperglycemia I (time frame: Up to 10 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.