Actively Recruiting
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2024-10-22
75
Participants Needed
1
Research Sites
N/A
Total Duration
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
E
European Society of Anaesthesiology and Intensive Care
Collaborating Sponsor
Researchers are investigating whether time-restricted feeding, a type of intermittent fasting, before surgery can improve insulin resistance around the time of surgery. This study compares time-restricted feeding with carbohydrate drinks and standard fasting methods in patients undergoing elective orthopedic surgery. The study is randomized and aims to evaluate the effects on insulin resistance after surgery. Participants in the time-restricted feeding group will follow a daily schedule of eating freely for 8 hours and fasting with water for 16 hours during the two weeks before surgery, followed by routine preoperative fasting. Those in the carbohydrate loading group will maintain their usual diet but receive maltodextrin drinks the evening before surgery and two hours before anesthesia. A control group will continue their usual diet and follow standard preoperative fasting rules. During the study, participants will be monitored for insulin resistance on the first day after surgery, along with changes in insulin function and overall wellbeing before and after surgery. Researchers will collect data on insulin resistance and beta-cell function, and patients will be observed throughout the two weeks before surgery up to one day postoperatively. The total involvement includes the pre-surgical diet plans, surgery, and postoperative assessments.
CONDITIONS
Intermittent Fasting Versus Carbohydrate Drinks Before Surgery
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 weeks before surgery
Participants follow a time-restricted feeding regimen consisting of an 8-hour eating period and a 16-hour water fasting period daily during the last two weeks before surgery, or they continue their usual diet with carbohydrate beverage intake before surgery, or continue usual diet with standard preoperative fasting.
Instructions and adherence monitored during the two weeks preoperatively
Duration - Day of surgery
Participants undergo routine preoperative fasting and surgery according to standard hospital procedures.
1 day with beverage intake for carbohydrate loading group before surgery
Duration - 1 day after surgery
Participants are monitored for insulin resistance and patient wellbeing on the day after surgery.
1 visit (in-person) on postoperative day 1
Total: 1 location
1
Amsterdam UMC location AMC
Amsterdam, North Holland, Netherlands, 1105AZ
Actively Recruiting
A
A. Stobbe, MSc
B
Benedikt Preckel, MSc
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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Ayla Y Stobbe, Eline S de Klerk, Robert van Wilpe...
https://pubmed.ncbi.nlm.nih.gov/39842917