Hyperglycemia Steroid-inducedNCT04021186
An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients.
A study testing Prevention of hyperglycemia in people with Hyperglycemia Steroid-induced and Hyperglycemia Stress, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Based on glycemic load (overall increase in blood glucose), it is investigated whether better glycemic control (large fluctuations in blood glucose to abnormal values are attempted) can improve the postoperative phase of head and neck surgical patients who receive Dexamethasone (glucocorticoid). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia Steroid-induced, Hyperglycemia Stress, Surgery--Complications
- What is being tested?
- Prevention of hyperglycemia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jul 2019to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- All embedded head and neck-surgical patients receiving large packs of pre-medication, including 8-16 mg glucocorticoid.
- >18 yrs.
- Expected admission time of a minimum of 1 day
Who cannot join
- Patients who do not understand and / or speak Danish
- Patients who are demented
- Patients included in primary robot surgery
- Ear-surgical patients
- Sinus surgery patients
- Day surgery patients
Show all 14Show fewer
- Plastic surgical patients
- Patients who are scheduled to transfer to ICU
- Patients with Diabetes Mellitus type I
- Patients on dialysis
- If all preoperative blood samples and tests are not completed
- Type 2 diabetics in insulin therapy
- Anesthesia patients
- Patients who have received large packages of pre-medication twice - eg. due to cancelled operation.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Clinic for Ear, Nose and Throat Surgery, Rigshospital
Copenhagen, 2100 Cph OE
Jens R Andersen, MD, MPA, +4523346654, jra@life.ku.dk
Irene Wessel, MD. PhD
About this study
Official title: An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients -- Improvement in Glycemic Control to Reduce the Incidence of Hyperglycaemia and Associated Complications.
Based on glycemic load (overall increase in blood glucose), it is investigated whether better glycemic control (large fluctuations in blood glucose to abnormal values are attempted) can improve the postoperative phase of head and neck surgical patients who receive Dexamethasone (glucocorticoid). Furthermore it is examined whether this optimization in treatment can result in reduced hospitalization time and fewer re-admissions.
Hypothesis:
Continuous blood glucose measurement and insulin therapy will optimize the postoperative phase of the embedded head and neck patient receiving Dexamethasone by reducing the incidence of hyperglycaemia and associated complications.
Read the detailed description
After surgical intervention, an insulin resistance condition will occur because of the following stress response. This condition will for the majority of cases results in poor glycemic control - and there will be a risk of hyperglycaemia in the hospitalized patient. This condition affects all cells in the body and therefore has associated complications such as bigger risk at multiple infections, longer healingprocess, poorer fluid balance, etc. Hyperglycaemia is associated with a poorer outcome for the patient, which can cause an increase in hospitalization days and multiple re-admissions. It is also common for the postoperative patient to experience nausea and pain as a result of both surgery and anesthesia and immobilization. To counter this, the patient receives Dexamethasone (steroid treatment).
This experiment is based on the fact that there is still insufficient attention at this postoperative insulin resistance. In a large randomized study from 2001(Van den Berghe), insulin therapy was initiated for intensive patients. This study points out that even moderate increases in blood glucose are associated with increased morbidity and that insulin therapy is both capable of reducing mortality and morbidity.
- Being tested
- Prevention of hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention of hyperglycemiaOther
Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Insulin treatment using standard measurements. Receives: Other: Prevention of hyperglycemia |
| Control | No intervention | Standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic load (mmol)
All blood glucose levels of the participants will be measured every 30. min - all values will be used to make an area under the curve in final statistics.
Measured: 1-5 days
Secondary outcomes (9)
Temperature (degree celcius)
The temperature will be measured 3 times a day for each participant
Measured: 1-5 days
C-Peptide
Blood sample - Will be measured 3 times
Measured: 1-5 days
Strength of Hand grip (kg)
Will be measured 3 times. Maximal values of 3 attempts
Measured: 20 days
Number of re-Hospitalizations
counted
Measured: 30 days postoperatively
Number of re-Hospitalizations
counted
Measured: Up to 3 months after the first discharge
Intracellular hydration (liters)
Will be measured by bioimpedance and blood sample of hematocrit
Measured: 20 days
C-reactive protein (CRP) concentration
Blood sample - will be measured 3 times
Measured: 20 days
Blood glucose (mmol/l)
Will be measured by electronical device called Freestyle Libre (CGM)
Measured: 1-5 days - every 30. min.
Functional recovery
Performa status and FOIS (Functional Oral Intake Scale = degree of swallowing problems/dysphagia) scale will be used (points 1-7)
Measured: 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start5 Jul 2019
- Primary completion17 Aug 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperglycemia Steroid-inducedStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prevention of hyperglycemia. The study will involve an intervention and a control group - only the intervention group will receive different treatment and the other standard care.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Jens R. Andersen, AP, MD, MPA, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021186
- Sponsor's protocol ID
- DM-HHC
- Status last verified
- Jul 2019
- First submitted
- 5 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nielsen SK, Olsen JQ, Jalili M, Wessel I, Andersen JR. Postoperative glycemic control in head and neck surgery. Clin Nutr ESPEN. 2025 Aug;68:691-698. doi: 10.1016/j.clnesp.2025.06.024. Epub 2025 Jun 13.
PubMed 40518009
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optimization in the Postoperative Treatment in Head and Neck--surgical Patients -- Improvement in Glycemic Control to Reduce the Incidence of Hyperglycaemia and Associated Complications.
- ClinicalTrials.gov ID
- NCT04021186
- Acronym / sponsor ID
- DM-HHC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 17 Aug 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 16 Jul 2019 (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.
Based on glycemic load (overall increase in blood glucose), it is investigated whether better glycemic control (large fluctuations in blood glucose to abnormal values are attempted) can improve the postoperative phase of head and neck surgical patients who receive Dexamethasone (glucocorticoid). Furthermore it is examined whether this optimization in treatment can result in reduced hospitalization time and fewer re-admissions.
Hypothesis:
Continuous blood glucose measurement and insulin therapy will optimize the postoperative phase of the embedded head and neck patient receiving Dexamethasone by reducing the incidence of hyperglycaemia and associated complications.
Detailed description
After surgical intervention, an insulin resistance condition will occur because of the following stress response. This condition will for the majority of cases results in poor glycemic control - and there will be a risk of hyperglycaemia in the hospitalized patient. This condition affects all cells in the body and therefore has associated complications such as bigger risk at multiple infections, longer healingprocess, poorer fluid balance, etc. Hyperglycaemia is associated with a poorer outcome for the patient, which can cause an increase in hospitalization days and multiple re-admissions. It is also common for the postoperative patient to experience nausea and pain as a result of both surgery and anesthesia and immobilization. To counter this, the patient receives Dexamethasone (steroid treatment).
This experiment is based on the fact that there is still insufficient attention at this postoperative insulin resistance. In a large randomized study from 2001(Van den Berghe), insulin therapy was initiated for intensive patients. This study points out that even moderate increases in blood glucose are associated with increased morbidity and that insulin therapy is both capable of reducing mortality and morbidity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prevention of hyperglycemia. The study will involve an intervention and a control group - only the intervention group will receive different treatment and the other standard care.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Prevention of hyperglycemiaInsulin treatment using standard measurements. |
| Control | No intervention | –Standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All embedded head and neck-surgical patients receiving large packs of pre-medication, including 8-16 mg glucocorticoid.
- >18 yrs.
- Expected admission time of a minimum of 1 day
Key exclusion criteria (14 listed)
- Patients who do not understand and / or speak Danish
- Patients who are demented
- Patients included in primary robot surgery
- Ear-surgical patients
- Sinus surgery patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevention of hyperglycemiaBigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications. | Other | Intervention |
Primary outcome
Glycemic load (mmol)
Time frame: 1-5 days
All blood glucose levels of the participants will be measured every 30. min - all values will be used to make an area under the curve in final statistics.
9 secondary outcomes
Temperature (degree celcius)
Time frame: 1-5 days
C-Peptide
Time frame: 1-5 days
Strength of Hand grip (kg)
Time frame: 20 days
Number of re-Hospitalizations
Time frame: 30 days postoperatively
Number of re-Hospitalizations
Time frame: Up to 3 months after the first discharge
Intracellular hydration (liters)
Time frame: 20 days
C-reactive protein (CRP) concentration
Time frame: 20 days
Blood glucose (mmol/l)
Time frame: 1-5 days - every 30. min.
Functional recovery
Time frame: 20 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Derived from this study: PubMed 40518009Nielsen SK, Olsen JQ, Jalili M, Wessel I, Andersen JR. Postoperative glycemic control in head and neck surgery. Clin Nutr ESPEN. 2025 Aug;68:691-698. doi: 10.1016/j.clnesp.2025.06.024. Epub 2025 Jun 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jens R. Andersen, AP, MD, MPA principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention of hyperglycemia in people with Hyperglycemia Steroid-induced and Hyperglycemia Stress, run by University of Copenhagen 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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 17 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara K. Nielsen, Stud.Cand (29456529 ext. +45, qcw694@alumni.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic load (mmol) (time frame: 1-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04021186, which also lists 1 linked publication.
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 17 Jul 2019; AzTrials last refreshed its copy on 2 Nov 2026.