no specific disease (patients undergoing orthopaedic surgery)
Conditions
Interventions
Patients in the 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 pr
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult patients, above 18 years old; - 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
Exclusion criteria: - History of diabetes mellitus; - History of feeding or eating disorders; - History of delayed gastric emptying or gastroesophageal reflux - Active malignancy - Patients classified as ASA IV by the attending anaesthetist; - BMI = 35; - Outpatient or day case surgery; - Palliative surgery; - Participation in another clinical trial that is inferfering 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 |
|---|---|
| The primary outcome will be insulin resistance according to the homeostasis model of insulin resistance (HOMA-IR) on postoperative day 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Decrease of HOMA-IR on postoperative day 1 compared to baseline - HOMA-IR on the morning of surgery (day 0) - Beta-cell function and insulin resistance based on the updated HOMA model (HOMA2) on day 0 and postoperative day 1 - Mean duration of the feeding period in the last 14 days before surgery - Glucose, C-peptide and insulin on day 0 and postoperative day 1 - The EQ-5D-5L utility score at multiple timepoints (see study protocol) - Quality of Recovery-15 (QoR-15) score on day 0 and postoperative day 1 - Change in body weight in the last 2 weeks before surgery - Average daily caloric intake during the last 2 weeks before surgery | — |
Countries
Netherlands
Outcome results
None listed