Preoperative Carbohydrate Loading in Diabetic Patients Undergoing Elective Abdominal Surgery (CARB-DM)

March 5, 2026 updated by: Ibrahim Abdelbaset Abdelkhalik, Tanta University

"A Randomized Controlled Trial on the Effect of Preoperative Carbohydrate Loading in Diabetic and Non-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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt
        • Tanta University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group I - Nondiabetic Control
Yogurt + honey at midnight, 200 ml water 2h pre-op
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.
Other Names:
  • Routine fasting protocol
Active Comparator: Group II - Nondiabetic CHO
Yogurt + honey at midnight, 200 ml carbohydrate drink 2h pre-op
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.
Other Names:
  • Oral carbohydrate drink
Active Comparator: Group III - Diabetic CHO
Yogurt + honey at midnight, 200 ml carbohydrate drink 2h pre-op
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.
Other Names:
  • Oral carbohydrate drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperative (immediately before induction of anesthesia)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative period (within 24 hours after surgery)
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.
Preoperative and 6 hours after carbohydrate loading
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.
Within 24 hours postoperatively
Length of Hospital Stay
Time Frame: From surgery until discharge (up to 7 days)
Total number of days from surgery until hospital discharge.
From surgery until discharge (up to 7 days)
Time to Independent Ambulation
Time Frame: Within the first 48 hours postoperatively
Time required for the patient to achieve independent ambulation following surgery.
Within the first 48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUH-ANES-CARB-DM-2024-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including demographic, laboratory, and outcome measures, will be made available to qualified researchers upon reasonable request. Data will be shared through secure institutional channels after publication of the primary results. A data use agreement will be required to ensure participant confidentiality.

IPD Sharing Time Frame

De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary results, and will remain available for 3 years thereafter.

IPD Sharing Access Criteria

Data will be accessible to qualified researchers for academic and scientific purposes. Requests must include a research proposal and a signed data use agreement to ensure confidentiality. Access will be provided through secure institutional channels upon approval of the request. Shared data will include de-identified participant-level data, the study protocol, statistical analysis plan, informed consent form, and analytic code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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