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

Overview

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

Interventions

• 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)

Primary outcome measures

• Short Insulin Tolerance Test (KITT) [Time frame: Preoperatively and up to 72 hours postoperatively]

Secondary outcome measures (8)

• CRP levels [Time frame: Preoperatively and up to 72 hours postoperatively]
• Arterial blood gases [Time frame: Preoperatively and up to 72 hours postoperatively]
• Operative time [Time frame: Intraoperatively, skin-to-skin]
• CPB duration [Time frame: Intraoperatively, using extracorporeal circulation]
• Blood loss [Time frame: Intraoperatively and up to 72 hours postoperatively]
• Number of grafts performed [Time frame: Intraoperatively, skin-to-skin]
• Use of inotrops [Time frame: Intraoperatively and up to 72 hours postoperatively]
• Complications [Time frame: Intraoperatively and up to 72 hours postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Syria · 1 center

• Damascus University Cardiac Surgery Hospital — Damascus

Publications

• Dock-Nascimento DB, de Aguilar-Nascimento JE, Magalhaes Faria MS, Caporossi C, Slhessarenko N, Waitzberg DL. Evaluation of the effects of a preoperative 2-hour fast with maltodextrine and glutamine on insulin resistance, acute-phase response, nitrogen balance, and serum glutathione after laparoscopic cholecystectomy: a controlled randomized trial. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1):43-52 PMID 22235107
• Vermeulen MA, Richir MC, Garretsen MK, van Schie A, Ghatei MA, Holst JJ, Heijboer AC, Uitdehaag BM, Diamant M, Eekhoff EM, van Leeuwen PA, Ligthart-Melis GC. Gastric emptying, glucose metabolism and gut hormones: evaluation of a common preoperative carbohydrate beverage. Nutrition. 2011 Sep;27(9):897-903. doi: 10.1016/j.nut.2010.10.001. Epub 2011 Jan 21. PMID 21255977
• Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7. PMID 28385477
• Breuer JP, von Dossow V, von Heymann C, Griesbach M, von Schickfus M, Mackh E, Hacker C, Elgeti U, Konertz W, Wernecke KD, Spies CD. Preoperative oral carbohydrate administration to ASA III-IV patients undergoing elective cardiac surgery. Anesth Analg. 2006 Nov;103(5):1099-108. doi: 10.1213/01.ane.0000237415.18715.1d. PMID 17056939
• Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21. PMID 28000931
• Sokolic J, Knezevic D, Kuharic J, Medved I, Sustic A, Zupan Z, Laskarin G, Tadin T, Sotosek Tokmadzic V. Decrease of Perforin Expressing Lymphocytes after On-Pump Coronary Artery Bypass Grafting Surgery Irrespective of Carbohydrate Preoperative Oral Feeding. Heart Surg Forum. 2019 May 22;22(3):E218-E224. doi: 10.1532/hsf.2003. PMID 31237547
• Lee B, Soh S, Shim JK, Kim HY, Lee H, Kwak YL. Evaluation of preoperative oral carbohydrate administration on insulin resistance in off-pump coronary artery bypass patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):740-747. doi: 10.1097/EJA.0000000000000637. PMID 28437263
• Rapp-Kesek D, Stridsberg M, Andersson LG, Berne C, Karlsson T. Insulin resistance after cardiopulmonary bypass in the elderly patient. Scand Cardiovasc J. 2007 Apr;41(2):102-8. doi: 10.1080/14017430601050355. PMID 17454835

Identifiers

NCT: NCT06951308 · PhD2-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗