NCT07451015

Preoperative Carbohydrate Loading in Diabetic Patients Undergoing Elective Abdominal Surgery

"A Randomized Controlled Trial on the Effect of Preoperative Carbohydrate Loading in Diabetic and Non-Diabetic Patients Undergoing Elective Abdominal Surgery"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of preoperative carbohydrate loading on early postoperative recovery in patients with type 2 diabetes mellitus undergoing elective abdominal surgery. Traditionally, patients fast before surgery, which can increase insulin resistance, delay recovery, and worsen postoperative outcomes. Preoperative carbohydrate drinks may reduce surgical stress and improve recovery, but concerns exist regarding blood glucose control and gastric emptying in diabetic patients. In this randomized, double-blind clinical trial, 120 eligible patients will be assigned to three groups: nondiabetic control, nondiabetic with carbohydrate load, and diabetic with carbohydrate load. Patients will receive either a carbohydrate-rich drink or control solution before surgery. Preoperative gastric residual volume will be measured using ultrasound to assess aspiration risk. Blood glucose levels will be measured before and after carbohydrate intake. Postoperative outcomes including metabolic and inflammatory response, nausea and vomiting, length of hospital stay, and time to independent ambulation will be recorded. The study aims to determine whether preoperative carbohydrate loading is safe and beneficial for diabetic patients undergoing elective abdominal surgery.

Detailed description

This prospective randomized controlled double-blinded study will be conducted at Tanta University Hospitals from June 2024 to June 2025. A total of 120 adult patients (aged 21-65 years, ASA I-II) undergoing elective abdominal surgery will be enrolled. Patients will be randomly assigned to one of three groups: nondiabetic control, nondiabetic carbohydrate load, or diabetic carbohydrate load. The primary outcome is preoperative gastric residual volume measured by ultrasound. Secondary outcomes include postoperative metabolic and inflammatory response, perioperative blood glucose levels, incidence of nausea and vomiting, length of hospital stay, and time to independent ambulation. Patients will receive a standardized preoperative meal of yogurt and honey at midnight, with either a clear carbohydrate drink or water administered two hours before anesthesia induction. Gastric ultrasound will be performed pre-induction to assess aspiration risk. Standard general anesthesia protocols will be used, and all patients will be monitored perioperatively. Ethical approval has been obtained, and informed consent will be collected from all participants. Data confidentiality and patient privacy will be strictly maintained.

Conditions

• Type 2 Diabetes Mellitus
• Elective Abdominal Surgery
• Gastric Emptying
• Postoperative Recovery

Interventions

Type	Name	Description
BEHAVIORAL	Standard Preoperative Fasting With Water	Participants receive 100 ml yogurt mixed with approximately 42 g honey at midnight before surgery. Two hours before induction of anesthesia, they receive 200 ml of clear water. No carbohydrate-rich clear drink is administered preoperatively. This represents the standard preoperative fasting protocol used in the control group.
BEHAVIORAL	Preoperative Oral Carbohydrate Loading	Participants receive 100 ml yogurt mixed with approximately 42 g honey at midnight before surgery. Two hours before induction of anesthesia, they receive 200 ml of a clear carbohydrate drink consisting of 200 ml water with two spoonfuls (approximately 42 g) of honey dissolved. This intervention is administered preoperatively to reduce perioperative insulin resistance and improve metabolic response.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2026-03-05
• Last updated: 2026-03-09

Locations

1 site across 1 country: Egypt