Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Insulin resistance on postoperative day 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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).
Outcomes
Primary Outcomes
Insulin resistance on postoperative day 1
Time Frame: Postoperative day 1
Insulin resistance according to the updated homeostasis model assessment of insulin resistance (HOMA2-IR)
Secondary Outcomes
- 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.)
- Beta-cell function(The day of surgery and the first postoperative day)
- Patient wellbeing(During the two weeks preoperatively, until one day postoperatively)
Investigators
B Preckel
Prof. dr.
Amsterdam UMC, location AMC