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Open Access 01-12-2022 | Insulins | Study protocol

Effects of pre-operative oral carbohydrates on insulin resistance and postoperative recovery in diabetic patients undergoing coronary artery bypass grafting: study protocol for a prospective, single-blind, randomized controlled trial

Authors: Shicheng Zhang, Lixian He, Yiping Yu, Xin Yuan, Tao Yang, Fuxia Yan, Fei Xu, Yan Zhang, Shiwei Pan, Huaijun Zhang, Zujun Chen, Lu Xie, Rong Wu, Wei Feng, Yuntai Yao, Evidence In Cardiovascular Anesthesia (EICA) Group

Published in: Trials | Issue 1/2022

Abstract

Background

Preoperative carbohydrates (CHO) supplement has been widely investigated in nondiabetic patients undergoing a variety of surgeries. It has been proved that preoperative CHO could alleviate postoperative insulin resistance (IR) and improve patients’ well-being in nondiabetic patients. However, it remains controversial whether preoperative CHO could yield similar effects in diabetic patients. Till now, seldom has the administration of preoperative CHO been investigated in diabetic patients and there are limited studies reporting IR and postoperative recovery of diabetic patients undergoing cardiac surgery.

Methods and analysis

We present a prospective, single-center, single-blind, randomized, no-treatment controlled trial of preoperative CHO on diabetic patients undergoing off-pump coronary artery bypass grafting (OPCAB). A total of 62 patients will be enrolled and randomized to either Group CHO or Group control (CTRL). Patients in Group CHO will consume CHO fluid containing 50 g carbohydrates orally the evening before surgery (20:00–24:00) while their counterparts in Group CTRL will be fasted after 20:00 the evening before surgery. The primary endpoint is postoperative IR assessed via homeostasis model assessment (HOMA). The secondary endpoints are postoperative levels of potential mediators relating to IR including inflammatory factors and stress reaction characterized by serum cortisol. Exploratory endpoints are in-hospital clinical endpoints. Continuous variables will be compared by Student’s t-test or Mann-Whitney U test. Categorical variables will be compared with χ² test or Fisher’s exact test. All tests in the present study are two-tailed and P<0.05 is considered statistically significant. All analyses will be performed with R 4.0.4.

Discussion

This is the first prospective randomized controlled trial of preoperative CHO in diabetic patients undergoing cardiac surgery, with the hypothesis that preoperative CHO could improve postoperative IR and promote postoperative recovery. The research may assist in improving the clinical outcomes of diabetic patients undergoing OPCAB.

Trial registration

The trial has been prospectively registered with ClinicalTrials.gov (https://register.clinicaltrials.gov) and Chinese Clinical Trial Registry (http://www.chictr.org.cn). Registry number is NCT05540249 and ChiCTR2000029664 respectively. Registered on Sept. 14, 2022.

Clinical trials unit

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.

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Title: Effects of pre-operative oral carbohydrates on insulin resistance and postoperative recovery in diabetic patients undergoing coronary artery bypass grafting: study protocol for a prospective, single-blind, randomized controlled trial
Authors: Shicheng Zhang
Lixian He
Yiping Yu
Xin Yuan
Tao Yang
Fuxia Yan
Fei Xu
Yan Zhang
Shiwei Pan
Huaijun Zhang
Zujun Chen
Lu Xie
Rong Wu
Wei Feng
Yuntai Yao
Evidence In Cardiovascular Anesthesia (EICA) Group
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Insulins
CABG
Diabetes
CABG
Insulins
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-07042-w

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Effects of pre-operative oral carbohydrates on insulin resistance and postoperative recovery in diabetic patients undergoing coronary artery bypass grafting: study protocol for a prospective, single-blind, randomized controlled trial

Abstract

Background

Methods and analysis

Discussion

Trial registration

Clinical trials unit

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods and analysis

Discussion

Trial registration

Clinical trials unit

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