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NCT Number: NCT07451015

Preoperative Carbohydrate Loading in Diabetic Patients Undergoing Elective Abdominal Surgery

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Elective Abdominal Surgery Endocrine System Diseases Gastric Emptying Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Postoperative Recovery

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 21-65 years

Both males and females

American Society of Anesthesiologists (ASA) physical status I-II

Scheduled for elective abdominal surgery under general anesthesia

Able and willing to provide informed consent

Exclusion criteria

Patient refusal

Known liver or renal pathology affecting gastric function

Mental dysfunction or cognitive disorders impairing consent or cooperation

Increased risk of gastric content aspiration

Body mass index (BMI) < 20 or > 35 kg/m²

Prior upper gastrointestinal surgery

Use of medications affecting gastric motility

Type 1 diabetes mellitus

Type 2 diabetes mellitus treated with insulin

Patients with clinical evidence of diabetic gastropathy or autonomic dysfunction

Treatment and study plan

Standard Preoperative Fasting With Water

Behavioral

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.

Other names: Routine fasting protocol

Preoperative Oral Carbohydrate Loading

Behavioral

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.

Other names: Oral carbohydrate drink

Primary outcomes

  1. Preoperative Gastric Residual Volume Measured by Ultrasound

    Time frame: Preoperative (immediately before induction of anesthesia)

    Gastric residual volume (GRV) will be assessed preoperatively using gastric ultrasound examination in the right lateral position. Cross-sectional area measurements will be used to calculate gastric volume using a validated formula. This outcome evaluates gastric emptying and aspiration risk prior to anesthesia induction.

Secondary outcomes

  1. Postoperative Metabolic and Inflammatory Response (Glasgow Prognostic Score)

    Time frame: Postoperative period (within 24 hours after surgery)

    The postoperative inflammatory and metabolic response will be assessed using the Glasgow Prognostic Score (GPS), based on C-reactive protein and serum albumin levels.

  2. Perioperative Random Blood Glucose Levels

    Time frame: Preoperative and 6 hours after carbohydrate loading

    Random blood glucose (RBG) levels will be measured at three time points: before carbohydrate loading, 2 hours pre-induction, and 6 hours after carbohydrate administration.

  3. Incidence of Postoperative Nausea and Vomiting (PONV)

    Time frame: Within 24 hours postoperatively

    Occurrence of nausea and/or vomiting within the first 24 hours after surgery.

  4. Length of Hospital Stay

    Time frame: From surgery until discharge (up to 7 days)

    Total number of days from surgery until hospital discharge.

  5. Time to Independent Ambulation

    Time frame: Within the first 48 hours postoperatively

    Time required for the patient to achieve independent ambulation following surgery.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Acronym: CARB-DM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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