Perioperative Care, Intermittent Fasting, Carbohydrate Loading, Preoperative Fasting, Orthopedic Surgery, Insulin Resistance
Conditions
Keywords
Perioperative Care, Carbohydrate Loading, Orthopedic Surgery, Insulin Resistance, HOMA-IR, Time Restricted Feeding
Brief summary
The purpose of this study is to investigate whether time-restricted feeding, a form of intermittent fasting, before surgery improves insulin resistance around the time of surgery, compared to carbohydrate drinks and standard fasting before surgery.
Detailed description
Patients in the Time-Restricted Feeding (TRF) group will follow a daily TRF regimen consisting of an 8h ad libitum eating period and a 16h water fasting period during the last two weeks before surgery, followed by routine preoperative fasting before surgery. Patients in the CarboHydrate Loading (CHL) group will follow their usual diet in the pre-surgical weeks and will receive a maltodextrin beverage on the evening before surgery, as well as two hours before induction of anaesthesia.
Interventions
BEHAVIORALTime-restricted feeding
Subjects in the will be instructed to follow a TRF regimen consisting of a daily 8h ad libitum eating period and 16h water fasting period during the last 2 weeks before surgery. Participants will be encouraged to begin their eating period at 08:00h and end it at 16:00h, since the metabolic benefits of TRF appear to be considerably more pronounced when the eating period starts early in the day.
DIETARY_SUPPLEMENTCarbohydrate loading
Subjects will continue their usual diet and will receive two quantities of a clear beverage containing 12.5 g/100 mL maltodextrin (50 kCal/100 mL, pH 5.0); 800 mL at 22.00h on the evening before surgery and 400 mL two hours before anaesthesia induction.
Sponsors
European Society of Anaesthesiology and Intensive Care
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing elective orthopaedic surgery; * Intermediate, major or complex surgery according to the Surgical Outcome Risk Tool (SORT; http://www.sortsurgery.com/) severity of surgery classification; * Scheduled for surgery at least 17 days from the date of screening; * Motivated to follow a time restricted feeding regimen. * Willing and able to provide written informed consent.
Exclusion criteria
* History of diabetes mellitus; * History of feeding or eating disorders; * History of delayed gastric emptying or gastro-oesophageal reflux * Active malignancy * Patients classified as ASA IV by the attending anaesthetist; * BMI \< 18.5 or ≥ 35; * Outpatient or day case surgery; * Palliative surgery; * Participation in another clinical trial that is interfering with the procedures or outcomes of the PRINCESS trial; * Patients unable to fully comply to study needs (e.g. legally incapable patients or patients unable to communicate in Dutch).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance on postoperative day 1 | Postoperative day 1 | Insulin resistance according to the updated homeostasis model assessment of insulin resistance (HOMA2-IR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in HOMA2-IR | From baseline to day of surgery, from baseline to postoperative day 1 and from day of surgery to postoperative day 1. | This is a calculated value between two timepoints, in contrary to the primary outcome that solely measures postoperative insulin resistance. The preoperative HOMA2-IR and the postoperative HOMA2-IR are used to determine whether there has been a change (increase or decrease) of the insulin resistance. |
| Beta-cell function | The day of surgery and the first postoperative day | The beta-cell function is based on the updated HOMA2 model. In addition to glucose and insulin, C-peptide measurements will be done to calculate HOMA2-B. |
| Patient wellbeing | During the two weeks preoperatively, until one day postoperatively | Patient wellbeing during and after the intervention and on the first postoperative day is measured by combining the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L) utility score (change in scores 1-5 over 5 domains, 1 is best and 5 is worst), and the Quality of Recovery-15 (QoR-15) score (0-150, 0 is the worst and 150 is the best recovery). |
Countries
Netherlands
Contacts
Primary ContactA. Stobbe, MSc
Backup ContactBenedikt Preckel, MSc
Outcome results
None listed