Efficacy of Carbohydrate Loading in Diabetic Type 2 Patients Undergoing CABG Surgery on CPB (CLDM-CABG)

March 17, 2026 updated by: Damascus University
Enhanced recovery after surgery protocols aim to optimize perioperative care and improve surgical outcomes. Preoperative carbohydrate loading has demonstrated benefits in reducing insulin resistance and improving patient outcomes. While non-diabetic patients benefit from this approach, its efficacy in diabetic type 2 patients undergoing CABG remains less understood. This study aims to address this gab by evaluating the physiological and clinical outcomes for carbohydrate loading in this specific population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial comparing diabetic type 2 patients receiving carbohydrate loading with those undergoing traditional fasting protocols. Patients will be randomized to two groups; group (a) patients will have carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade), while group (b) patients (control group) will have standard fasting protocol 8 hours before surgery.

Aims of the study:

  1. To assess the efficacy of carbohydrate loading in reducing insulin resistance in diabetic type 2 patients undergoing CABG surgeries.
  2. To monitor clinical outcomes such as infection rates, ICU stay duration, and need for inotropic and vasoactive drugs.
  3. To evaluate changes in inflammatory markers including CRP levels. clinical outcome

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

  • Name: Mohammad B Izzat, FRCS(CTh)
  • Phone Number: +963943240820
  • Email: mbizzat@gmail.com

Study Contact Backup

Study Locations

  • Syria
      • Damascus, Syria, Mazzeh
        • Recruiting
        • Damascus University Cardiac Surgery Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohammad B Izzat, FRCS(CTh)

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All diabetic type 2 patients undergoing isolated on-pump coronary artery bypass surgery.

Exclusion Criteria:

  • Missing data.
  • Patients outside the study period.
  • Patients undergoing other cardiac surgeries.
  • Patients diagnosed with type 1 diabetes mellitus.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention arm
Patients who will have carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade)
Dietary supplement: Carbohydrate loading before surgery
Carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade)
No Intervention: Control arm
Patients who will have standard fasting protocol 8 hours before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Insulin Tolerance Test (KITT)
Time Frame: Preoperatively and up to 72 hours postoperatively
Short Insulin Tolerance Test (KITT) will test changes in insulin tolerance postoperatively
Preoperatively and up to 72 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CRP levels
Time Frame: Preoperatively and up to 72 hours postoperatively
C-Reactive Protein levels in the blood
Preoperatively and up to 72 hours postoperatively
Arterial blood gases
Time Frame: Preoperatively and up to 72 hours postoperatively
Changes in arterial blood gases
Preoperatively and up to 72 hours postoperatively
Operative time
Time Frame: Intraoperatively, skin-to-skin
Total operative time, skin-to-skin
Intraoperatively, skin-to-skin
CPB duration
Time Frame: Intraoperatively, using extracorporeal circulation
Total time spend using cardiopulmonary bypass perfusion
Intraoperatively, using extracorporeal circulation
Blood loss
Time Frame: Intraoperatively and up to 72 hours postoperatively
Blood loss and blood product usage
Intraoperatively and up to 72 hours postoperatively
Number of grafts performed
Time Frame: Intraoperatively, skin-to-skin
Number of grafts performed during the operation
Intraoperatively, skin-to-skin
Use of inotrops
Time Frame: Intraoperatively and up to 72 hours postoperatively
Use of inotrops to support the cardiac output
Intraoperatively and up to 72 hours postoperatively
Complications
Time Frame: Intraoperatively and up to 72 hours postoperatively
All perioperative complications
Intraoperatively and up to 72 hours postoperatively

Collaborators and Investigators

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

Sponsor

Damascus University

Investigators

  • Study Director: Mohammad B Izzat, FRCS(CTh), Damascus 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)

April 1, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 26, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhD2-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD will be uploaded on a data sharing platform

IPD Sharing Time Frame

December 31, 2026, and will be available permanently

IPD Sharing Access Criteria

IPD will be open to all through a data sharing platform

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Study Data/Documents

  1. Study Protocol
    Information identifier: PhD2-2025
    Information comments: Open to enyone with link

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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