NCT04021186

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

July 5, 2019

Last Update Submit

July 16, 2019

Conditions

Hyperglycemia Steroid-inducedHyperglycemia StressSurgery--Complications

Outcome Measures

Primary Outcomes (1)

  • 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.

    1-5 days

Secondary Outcomes (9)

  • Temperature (degree celcius)

    1-5 days

  • C-Peptide

    1-5 days

  • Strength of Hand grip (kg)

    20 days

  • Number of re-Hospitalizations

    30 days postoperatively

  • Number of re-Hospitalizations

    Up to 3 months after the first discharge

  • +4 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Insulin treatment using standard measurements.

Other: Prevention of hyperglycemia

Control

NO INTERVENTION

Standard care.

Interventions

Prevention of hyperglycemiaOTHER

Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Ear, Nose and Throat Surgery, Rigshospital

Copenhagen, 2100 Cph OE, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40518009DERIVED

Study Officials

  • Jens R. Andersen, AP, MD, MPA

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara K. Nielsen, Stud.Cand

CONTACT

29456529qcw694@alumni.ku.dk

Josefine Q. Olsen, Stud.Cand

CONTACT

42232425bgc796@alumni.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor, MD, MPA

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 16, 2019

Study Start

July 5, 2019

Primary Completion

August 17, 2020

Study Completion

November 30, 2020

Last Updated

July 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)