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Efficacy of Carbohydrate Loading in Diabetic Type 2 Patients Undergoing CABG Surgery on CPB (CLDM-CABG)

D

Damascus University

Status

Enrolling

Conditions

Heart Surgery
Ischemic Heart Disease

Treatments

Dietary Supplement: Carbohydrate loading before surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06951308
PhD2-2025

Details and patient eligibility

About

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.

Full 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

Enrollment

50 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

Intervention arm
Active Comparator group
Description:
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)
Treatment:
Dietary Supplement: Carbohydrate loading before surgery
Control arm
No Intervention group
Description:
Patients who will have standard fasting protocol 8 hours before surgery

Trial contacts and locations

1

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Central trial contact

Mohammad B Izzat, FRCS(CTh); Mohammad S Sioufi, MD

Data sourced from clinicaltrials.gov

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