Study Overview of the PRINCESS Trial
The PRINCESS trial investigates how different preoperative nutritional strategies affect insulin resistance in orthopedic patients undergoing surgery.
Background
Surgery can cause metabolic stress, leading to insulin resistance (IR) and high blood sugar levels. This can result in complications after surgery. Traditional fasting before surgery may worsen these issues. However, strategies like carbohydrate loading (CHL) can help reduce postoperative IR. Recent studies show that time-restricted feeding (TRF), a type of intermittent fasting, may also improve IR.
Trial Details
This study is a randomized controlled trial involving 75 orthopedic patients at a Dutch hospital. Participants will be divided into three groups:
- Control group: Standard preoperative fasting
- TRF group: Short-term intermittent fasting
- CHL group: Carbohydrate loading
The main goal is to measure postoperative IR on the first day after surgery using a specific assessment method.
Ethics and Publication
The trial has been approved by the local medical ethics committee and will share results through a peer-reviewed journal.
Trial Registration
Registration Number: NCT05760339
Importance of Clinical Trials
Clinical trials are essential for developing safe and effective treatments. They help translate research findings into everyday medical practice.
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