NL-OMON53870RecruitingNot Applicable
Preoperative Intermittent Fasting versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial - The PRINCESS trial
Amsterdam UMC0 sites75 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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).
Investigators
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