About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
History of diabetes mellitus;
History of feeding or eating disorders;
History of delayed gastric emptying or gastro-oesophageal reflux
Active malignancy
Trial design
Parallel
Treatments tested in this trial
Time-restricted feeding
BehavioralSubjects 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.
Carbohydrate loading
Dietary supplementSubjects 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.
Treatment groups
Trial outcomes
Primary outcomes
Insulin resistance on postoperative day 1
Insulin resistance according to the updated homeostasis model assessment of insulin resistance (HOMA2-IR)
Secondary outcomes
Difference in HOMA2-IR
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 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
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).
Sponsors and contacts
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Amsterdam UMC, location AMC
Sponsor institution
European Society of Anaesthesiology and Intensive Care
Collaborator