ClinicalTrials.gg
RecruitingNCT06951308CLDM-CABGUpdated Sep 1, 2026

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

An interventional study of Carbohydrate loading before surgery in Heart Surgery and Ischemic Heart Disease, sponsored by Damascus University. Recruiting at 1 site in Syria. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Damascus University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Heart Surgery
  • Ischemic Heart Disease

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Keywords

  • Enhanced recovery program
  • carbohydrate loading
  • coronary artery bypass grafting
  • heart surgery
  • postoperative recovery
03

In context

Myocardial Ischemia

1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.

This study's planned enrollment of 50 is below the median of 116 across 622 interventional studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Missing data.
  • Patients outside the study period.
  • Patients undergoing other cardiac surgeries.
  • Patients diagnosed with type 1 diabetes mellitus.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • No intervention
    Control arm

    Patients who will have standard fasting protocol 8 hours before surgery

Interventions

  • Dietary supplementCarbohydrate 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)

06

What researchers measure

Primary outcomes

  1. Short Insulin Tolerance Test (KITT)

    Short Insulin Tolerance Test (KITT) will test changes in insulin tolerance postoperatively

    Time frame: Preoperatively and up to 72 hours postoperatively

Secondary outcomes

  1. CRP levels

    C-Reactive Protein levels in the blood

    Time frame: Preoperatively and up to 72 hours postoperatively

  2. Arterial blood gases

    Changes in arterial blood gases

    Time frame: Preoperatively and up to 72 hours postoperatively

  3. Operative time

    Total operative time, skin-to-skin

    Time frame: Intraoperatively, skin-to-skin

  4. CPB duration

    Total time spend using cardiopulmonary bypass perfusion

    Time frame: Intraoperatively, using extracorporeal circulation

  5. Blood loss

    Blood loss and blood product usage

    Time frame: Intraoperatively and up to 72 hours postoperatively

  6. Number of grafts performed

    Number of grafts performed during the operation

    Time frame: Intraoperatively, skin-to-skin

  7. Use of inotrops

    Use of inotrops to support the cardiac output

    Time frame: Intraoperatively and up to 72 hours postoperatively

  8. Complications

    All perioperative complications

    Time frame: Intraoperatively and up to 72 hours postoperatively

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. doi: 10.1177/0148607111422719. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 17454835 ↗
  • Jarvela K, Maaranen P, Sisto T. Pre-operative oral carbohydrate treatment before coronary artery bypass surgery. Acta Anaesthesiol Scand. 2008 Jul;52(6):793-7. doi: 10.1111/j.1399-6576.2008.01660.x. Epub 2008 May 12. PubMed 18477073 ↗
  • Feguri GR, Lima PR, Lopes AM, Roledo A, Marchese M, Trevisan M, Ahmad H, Freitas BB, Aguilar-Nascimento JE. Clinical and metabolic results of fasting abbreviation with carbohydrates in coronary artery bypass graft surgery. Rev Bras Cir Cardiovasc. 2012 Jan-Mar;27(1):7-17. doi: 10.5935/1678-9741.20120004. English, Portuguese. PubMed 22729296 ↗
  • 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. PubMed 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. PubMed 28427403 ↗
  • Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ. 1997 Sep 13;315(7109):629-34. doi: 10.1136/bmj.315.7109.629. PubMed 9310563 ↗
  • DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986 Sep;7(3):177-88. doi: 10.1016/0197-2456(86)90046-2. PubMed 3802833 ↗
  • Higgins JP, Altman DG, Gotzsche PC, Juni P, Moher D, Oxman AD, Savovic J, Schulz KF, Weeks L, Sterne JA; Cochrane Bias Methods Group; Cochrane Statistical Methods Group. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011 Oct 18;343:d5928. doi: 10.1136/bmj.d5928. PubMed 22008217 ↗
  • 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. PubMed 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. PubMed 33053694 ↗
  • Tran S, Wolever TM, Errett LE, Ahn H, Mazer CD, Keith M. Preoperative carbohydrate loading in patients undergoing coronary artery bypass or spinal surgery. Anesth Analg. 2013 Aug;117(2):305-13. doi: 10.1213/ANE.0b013e318295e8d1. Epub 2013 Jun 11. PubMed 23757474 ↗
  • Soop M, Nygren J, Thorell A, Weidenhielm L, Lundberg M, Hammarqvist F, Ljungqvist O. Preoperative oral carbohydrate treatment attenuates endogenous glucose release 3 days after surgery. Clin Nutr. 2004 Aug;23(4):733-41. doi: 10.1016/j.clnu.2003.12.007. PubMed 15297112 ↗
  • Braga M, Bissolati M, Rocchetti S, Beneduce A, Pecorelli N, Di Carlo V. Oral preoperative antioxidants in pancreatic surgery: a double-blind, randomized, clinical trial. Nutrition. 2012 Feb;28(2):160-4. doi: 10.1016/j.nut.2011.05.014. Epub 2011 Sep 3. PubMed 21890323 ↗

Individual participant data

Plan to share: Yes — All IPD will be uploaded on a data sharing platform

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: December 31, 2026, and will be available permanently

Access criteria: IPD will be open to all through a data sharing platform

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2025 to primary completion in Apr 2026, 12 months.

Of 155 non-industry interventional studies with no phase under Myocardial Ischemia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 56. This study's 12 months is below that.

Counting every sponsor, half of 192 studies reached it within 34 months; a quarter within 15 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 18, 2025
First posted
Apr 30, 2025
StartActual
Apr 1, 2025
Primary completionActual
Apr 30, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06951308
Responsible party
Sponsor
First posted
Apr 30, 2025
Start date
Apr 1, 2025
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026 (estimated)
Last update
Sep 1, 2026

Study contacts

Mohammad B Izzat, FRCS(CTh)
Contact
mbizzat@gmail.com
+963943240820
Mohammad S Sioufi, MD
Contact
m.s.sioufi@gmail.com
+963967788163
Mohammad B Izzat, FRCS(CTh)
study director · Damascus University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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