| Registry | NCT06951308, acronym CLDM-CABG |
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 50 (Estimated) |
| Sponsor | Damascus University (Other) |
| Conditions | Heart Surgery, Ischemic Heart Disease |
| Interventions | Carbohydrate loading before surgery (Dietary supplement) |
| Dates | start 2025-04-01, primary completion 2026-04-30, completion 2026-12-31 (estimated), first posted 2025-04-30, last updated 2026-09-01 |
| Locations | 1 site in Syria |
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-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.
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+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
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Intervention arm | Active comparator | Dietary Supplement: Carbohydrate loading before surgery | 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) |
| Control arm | No intervention | | Patients who will have standard fasting protocol 8 hours before surgery |
- 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)
+Outcome measures
Primary outcomes
- 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 outcomes
- 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
+Eligibility
Sex: All
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.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Damascus University Cardiac Surgery Hospital | Damascus | Syria | Recruiting |
+Publications
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- Feguri GR, Lima PRL, Franco AC, Cruz FRH, Borges DC, Toledo LR, Segri NJ, Aguilar-Nascimento JE. Benefits of Fasting Abbreviation with Carbohydrates and Omega-3 Infusion During CABG: a Double-Blind Controlled Randomized Trial. Braz J Cardiovasc Surg. 2019 Mar-Apr;34(2):125-135. doi: 10.21470/1678-9741-2018-0336. PMID 30916121
- Feguri GR, de Lima PRL, de Cerqueira Borges D, Toledo LR, Batista LN, E Silva TC, Segri NJ, de Aguilar-Nascimento JE. Preoperative carbohydrate load and intraoperatively infused omega-3 polyunsaturated fatty acids positively impact nosocomial morbidity after coronary artery bypass grafting: a double-blind controlled randomized trial. Nutr J. 2017 Apr 20;16(1):24. doi: 10.1186/s12937-017-0245-6. PMID 28427403
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- Savluk OF, Kuscu MA, Guzelmeric F, Gurcu ME, Erkilinc A, Cevirme D, Ogus H, Kocak T. Do preoperative oral carbohydrates improve postoperative outcomesin patients undergoing coronary artery bypass grafts? Turk J Med Sci. 2017 Dec 19;47(6):1681-1686. doi: 10.3906/sag-1703-19. PMID 29306223
- Kotfis K, Jamiol-Milc D, Skonieczna-Zydecka K, Folwarski M, Stachowska E. The Effect of Preoperative Carbohydrate Loading on Clinical and Biochemical Outcomes after Cardiac Surgery: A Systematic Review and Meta-Analysis of Randomized Trials. Nutrients. 2020 Oct 12;12(10):3105. doi: 10.3390/nu12103105. PMID 33053694
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+Investigators