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

Not Applicable

Recruiting

• Conditions: Heart Surgery; Ischemic Heart Disease

• Registration Number: NCT06951308
• Lead Sponsor: Damascus University

Brief Summary

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.

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 Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-01
• Study First Submitted: 2025-04-18
• Study First Submitted QC: 2025-04-26
• Last Update Submitted: 2025-04-26
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Short Insulin Tolerance Test (KITT)	Preoperatively and up to 72 hours postoperatively	Short Insulin Tolerance Test (KITT) will test changes in insulin tolerance postoperatively

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Damascus University Cardiac Surgery Hospital; 🇸🇾 Damascus, Syrian Arab Republic