Preoperative Intermittent Fasting versus Carbohydrate Loading to Reduce Insulin Resistance: a Randomised Controlled Trial

Recruiting

• Conditions: no specific disease (patients undergoing orthopaedic surgery); 10005944

• Registration Number: NL-OMON53870
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 75

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be insulin resistance according to the homeostasis<br /><br>model of insulin resistance (HOMA-IR) on postoperative day 1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Decrease of HOMA-IR on postoperative day 1 compared to baseline<br /><br>- HOMA-IR on the morning of surgery (day 0)<br /><br>- Beta-cell function and insulin resistance based on the updated HOMA model<br /><br>(HOMA2) on day 0 and postoperative day 1<br /><br>- Mean duration of the feeding period in the last 14 days before surgery<br /><br>- Glucose, C-peptide and insulin on day 0 and postoperative day 1<br /><br>- The EQ-5D-5L utility score at multiple timepoints (see study protocol)<br /><br>- Quality of Recovery-15 (QoR-15) score on day 0 and postoperative day 1<br /><br>- Change in body weight in the last 2 weeks before surgery<br /><br>- Average daily caloric intake during the last 2 weeks before surgery</p><br>