Heart SurgeryCLDM-CABGNCT06951308
Efficacy of Carbohydrate Loading in Diabetic Type 2 Patients Undergoing CABG Surgery on CPB
A study testing Carbohydrate loading before surgery in people with Heart Surgery and Ischemic Heart Disease, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Surgery, Ischemic Heart Disease
- What is being tested?
- Carbohydrate loading before surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSyria
- Study dates
- 1 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All diabetic type 2 patients undergoing isolated on-pump coronary artery bypass surgery.
Who cannot join
- Missing data.
- Patients outside the study period.
- Patients undergoing other cardiac surgeries.
- Patients diagnosed with type 1 diabetes mellitus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syria1 site, 1 recruiting
- Recruiting
Damascus University Cardiac Surgery Hospital
Damascus, Mazzeh
Mohammad B Izzat, FRCS(CTh), +963943240820, mbizzat@gmail.com
Mohammad S Sioufi, MD, +963967788163, m.s.sioufi@gmail.com
About this study
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:
- 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
- Conditions
- Heart Surgery, Ischemic Heart Disease
- Being tested
- Carbohydrate loading before surgery
- Keywords
- Enhanced recovery program, carbohydrate loading, coronary artery bypass grafting, heart surgery, postoperative recovery
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate loading before surgeryDietary supplement
Carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade)
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | 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) Receives: Dietary Supplement: Carbohydrate loading before surgery |
| Control arm | No intervention | Patients who will have standard fasting protocol 8 hours before surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Insulin Tolerance Test (KITT)
Short Insulin Tolerance Test (KITT) will test changes in insulin tolerance postoperatively
Measured: Preoperatively and up to 72 hours postoperatively
Secondary outcomes (8)
CRP levels
C-Reactive Protein levels in the blood
Measured: Preoperatively and up to 72 hours postoperatively
Arterial blood gases
Changes in arterial blood gases
Measured: Preoperatively and up to 72 hours postoperatively
Operative time
Total operative time, skin-to-skin
Measured: Intraoperatively, skin-to-skin
CPB duration
Total time spend using cardiopulmonary bypass perfusion
Measured: Intraoperatively, using extracorporeal circulation
Blood loss
Blood loss and blood product usage
Measured: Intraoperatively and up to 72 hours postoperatively
Number of grafts performed
Number of grafts performed during the operation
Measured: Intraoperatively, skin-to-skin
Use of inotrops
Use of inotrops to support the cardiac output
Measured: Intraoperatively and up to 72 hours postoperatively
Complications
All perioperative complications
Measured: Intraoperatively and up to 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Apr 2025
- Primary completion30 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Heart SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad B Izzat, FRCS(CTh), Study director, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951308
- Sponsor's protocol ID
- PhD2-2025
- Acronym
- CLDM-CABG
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be uploaded on a data sharing platform
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 22235107Vermeulen 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 21255977Weimann 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 28385477Breuer 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 17056939Amer 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 28000931Sokolic 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 31237547Lee 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 28437263Rapp-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 17454835Jarvela 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 18477073Feguri 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 22729296Feguri 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 30916121Feguri 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 28427403Egger 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 9310563DerSimonian 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 3802833Higgins 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Carbohydrate Loading in Diabetic Type 2 Patients Undergoing CABG Surgery on CPB
- ClinicalTrials.gov ID
- NCT06951308
- Acronym / sponsor ID
- CLDM-CABG / PhD2-2025
- Conditions
- Heart Surgery, Ischemic Heart Disease
- Keywords
- Enhanced recovery program, carbohydrate loading, coronary artery bypass grafting, heart surgery, postoperative recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Dietary Supplement: Carbohydrate loading before surgeryPatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All diabetic type 2 patients undergoing isolated on-pump coronary artery bypass surgery.
Key exclusion criteria (4 listed)
- Missing data.
- Patients outside the study period.
- Patients undergoing other cardiac surgeries.
- Patients diagnosed with type 1 diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate loading before surgeryCarbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade) | Dietary supplement | Intervention arm |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 22235107Dock-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.
- Background: PubMed 21255977Vermeulen 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.
- Background: PubMed 28385477Weimann 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.
- Background: PubMed 17056939Breuer 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.
- Background: PubMed 28000931Amer 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.
- Background: PubMed 31237547Sokolic 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.
- Background: PubMed 28437263Lee 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.
- Background: PubMed 17454835Rapp-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.
- Background: PubMed 18477073Jarvela 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.
- Background: PubMed 22729296Feguri 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.
- Background: PubMed 30916121Feguri 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.
- Background: PubMed 28427403Feguri 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.
- Individual participant dataSharing planned: Yes. All IPD will be uploaded on a data sharing platform
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad B Izzat, FRCS(CTh) study director
Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate loading before surgery in people with Heart Surgery and Ischemic Heart Disease, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad B Izzat, FRCS(CTh) (+963943240820, mbizzat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Insulin Tolerance Test (KITT) (time frame: Preoperatively and up to 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06951308, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.