The main objective is to investigate whether preoperative TRF improves perioperative insulin resistance compared to CHL and standard preoperative fasting.Our secondary objective is to investigate the feasibility of preoperative TRF in terms of…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be insulin resistance according to the homeostasis
model of insulin resistance (HOMA-IR) on postoperative day 1.
Secondary outcome
- 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
Background summary
Both carbohydrate loading (CHL) and time-restricted feeding (TRF) improve
insulin resistance, although these seem to be opposing interventions.
Considering the improvement of tissue repair and the reduction of oxidative
stress and ischaemia-reperfusion injury reported in preclinical studies, the
protective benefits of preoperative TRF may potentially extend beyond those of
CHL. We hypothesise that short-term preoperative TRF reduces insulin resistance
on the day after surgery, as compared to CHL and standard preoperative fasting.
Study objective
The main objective is to investigate whether preoperative TRF improves
perioperative insulin resistance compared to CHL and standard preoperative
fasting.
Our secondary objective is to investigate the feasibility of preoperative TRF
in terms of patient wellbeing and diet adherence.
Study design
This open-label randomised controlled trial compares the effect of short-term
preoperative TRF and CHL on perioperative insulin resistance. Patients planned
to undergo elective moderate to major orthopaedic surgery will be randomly
assigned to the control group (standard preoperative fasting), the TRF group or
the CHL group.
Intervention
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 preoperative fasting before surgery.
Patients in the 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 burden and risks
For the purpose of study measurements, 12mL of blood will be withdrawn at three
time points (baseline measurement at inclusion in the morning, preoperatively
on the morning of surgery, on the morning of postoperative day 1). No extra
study-related site visits will be required, since all blood samples will be
collected either during the patient*s visit to the preoperative screening
clinic, or during their hospital admission. Patients will be asked to fill in a
15-item questionnaire (the QoR-15) and 5-item questionnaire (the EQ-5D-5L) on
the morning of the day of surgery (preoperatively) and on postoperative day 1.
Following a daily TRF regimen and keeping a simple diet journal requires effort
and determination, albeit for a period of 14 days. Therefore, only patients who
are sufficiently motivated to change their feeding patterns can be included
into the study. Following a TRF regimen may have protective benefits for the
patients, such as improvement of tissue repair and a reduction of oxidative
stress. However, whether the effects of the intervention may extend towards
clinical benefits (e.g. faster recovery) is still unknown. Potential harms due
to the intervention are deemed minimal, as these regimens have already been
extensively researched in healthy individuals with no adverse effects observed.
Carbohydrate loading is a well-established preoperative intervention and is
part of the standard of care in patients (without diabetes) undergoing
different types of gastro-intestinal surgery in the Amsterdam UMC.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
- 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 < 18.5 or >= 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81556.018.22 |