Clinical trial NCT05760339: Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
Official title: Preoperative Intermittent Fasting Versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perioperative Care
Intermittent Fasting
Carbohydrate Loading
Preoperative Fasting
Orthopedic Surgery
Insulin Resistance
Keywords: Perioperative Care
Carbohydrate Loading
Orthopedic Surgery
Insulin Resistance
HOMA-IR
Time Restricted Feeding
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: European Society of Anaesthesiology and Intensive Care
First posted: 2023-03-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Insulin resistance on postoperative day 1
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Difference in HOMA2-IR
timeFrame: From baseline to day of surgery, from baseline to postoperative day 1 and from day of surgery to postoperative day 1.
measure: Beta-cell function
timeFrame: The day of surgery and the first postoperative day
measure: Patient wellbeing
timeFrame: During the two weeks preoperatively, until one day postoperatively
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC location AMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location AMC
name: Jeroen Hermanides, MSc
role: PRINCIPAL_INVESTIGATOR
References: