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NCT Number: NCT06951308

Efficacy of Carbohydrate Loading in Diabetic Type 2 Patients Undergoing CABG Surgery on CPB

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.

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Key information

Conditions

Heart Surgery Cardiovascular Diseases Heart Diseases Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Carbohydrate loading before surgery

Dietary Supplement

Carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade)

Primary outcomes

  1. 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

Secondary outcomes

  1. CRP levels

    Time frame: Preoperatively and up to 72 hours postoperatively

    C-Reactive Protein levels in the blood

  2. Arterial blood gases

    Time frame: Preoperatively and up to 72 hours postoperatively

    Changes in arterial blood gases

  3. Operative time

    Time frame: Intraoperatively, skin-to-skin

    Total operative time, skin-to-skin

  4. CPB duration

    Time frame: Intraoperatively, using extracorporeal circulation

    Total time spend using cardiopulmonary bypass perfusion

  5. Blood loss

    Time frame: Intraoperatively and up to 72 hours postoperatively

    Blood loss and blood product usage

  6. Number of grafts performed

    Time frame: Intraoperatively, skin-to-skin

    Number of grafts performed during the operation

  7. Use of inotrops

    Time frame: Intraoperatively and up to 72 hours postoperatively

    Use of inotrops to support the cardiac output

  8. Complications

    Time frame: Intraoperatively and up to 72 hours postoperatively

    All perioperative complications

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad B Izzat, FRCS(CTh)

CONTACT

[email protected]

+963943240820

Mohammad S Sioufi, MD

CONTACT

[email protected]

+963967788163

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Acronym: CLDM-CABG

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2025
Registry last updated
Mar 19, 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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