Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG

Effects of Pre-operative Oral Carbohydrates on Insulin Resistance and Postoperative Recovery in Diabetic Patients Undergoing Coronary Artery Bypass Grafting

Preoperative carbohydrates (CHO) supplement has been shown to alleviate postoperative insulin resistance (IR) in nondiabetic patients undergoing a variety of surgeries. However, it remains controversial whether preoperative CHO could yield similar effects in diabetic patients. Thus, the investigators design a randomized controlled trial investigating the impact of preoperative CHO on postoperative IR and clinical outcomes in diabetic patients undergoing cardiac surgery. The results of the study may give some clinical implications and further improve perioperative care for diabetic patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2; Insulin Resistance; Coronary Artery Bypass Surgery
• Intervention / Treatment: Dietary supplement: carbohydrates

Detailed Description

CHO supplement has been widely investigated in nondiabetic patients undergoing various surgeries. It has been proved that preoperative CHO could alleviate postoperative insulin resistance (IR) and improve patients' well-being in nondiabetic patients. However, whether preoperative CHO could yield similar effects in diabetic patients remains controversial. Till now, seldom has the administration of preoperative CHO been investigated in diabetic patients and few studies reported IR and postoperative recovery of diabetic patients undergoing cardiac surgery. The investigators 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 receive CHO fluid containing 50 g of carbohydrates 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 endpoints are postoperative insulin resistance (IR) assessed via homeostasis model assessment (HOMA). The secondary endpoints are the potential mediators relating to IR including inflammatory factors and stress reactions assessed by serum cortisol. Exploratory endpoints are in-hospital clinical endpoints.

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Previously diagnosed T2DM
2. Diagnosed with CAD with coronary angiography and indicated for OPCAB
3. Age between 18 and 75 years old
4. First operation in the morning and anesthesia induced around 8:00
5. Written informed consent by the patients

Exclusion Criteria:

1. Combined with other heart diseases or vascular malformations that require surgery in addition to OPCAB
2. Presence of symptoms or signs of heart failure such as orthopnea, distended jugular vein, lower extremity edema, etc.
3. Reduced LVEF (lower than 50%)
4. Combined with gastroesophageal reflux
5. Combined with thyroid insufficiency requiring replacement therapy with levothyroxine
6. Combined with adrenal insufficiency requiring replacement therapy with corticosteroids
7. Refuse to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group CHO; Patients in Group CHO will orally consume CHO 355ml containing 50 g of carbohydrates 8-12 hours before operation (20:00 -24:00 the evening before operation).	Dietary supplement: carbohydrates; Patients will orally consume 355mL CHO after 20:00 the evening before surgery.; Other Names: Outfast
No Intervention: Group CTRL; Patients in Group CTRL will consume no food or drink 12 hours before operation (20:00 the evening before operation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	Before anesthesia induction
Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	Immediately after surgery
Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	The first morning after surgery
Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	The second morning after surgery
Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	The third morning after surgery
Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	The fifth morning after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin -1 (IL-1)	Inflammatory factors	The first morning after surgery
Interleukin-6 (IL-6)	Inflammatory factors	The first morning after surgery
Interleukin-8 (IL-8),	Inflammatory factors	The first morning after surgery
Interleukin-10 (IL-10),	Inflammatory factors	The first morning after surgery
Tumor necrosis fator-α (TNF-α)	Inflammatory factors	The first morning after surgery
High-sensitivity C-reactive protein (hs-CRP)	Inflammatory factors	The first morning after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea or vomiting	Nausea or vomiting requiring medical treatment such as ondansetron	In-hospital period after surgery (up to day 5)
New-onset postoperative atrial fibrillation (POAF)	POAF is defined as new onset atrial fibrillation lasting at least 10min on the electrocardiogram (ECG) monitor or atrial fibrillation that requires treatment with medication after surgery.	In-hospital period after surgery (up to day 5)
Major adverse cardiovascular and cerebral events (MACCEs)	A composite endpoints of all-cause death, non-fatal myocardial infarction, stroke.	In-hospital period after surgery (up to day 5)
ICU length	The length of patient's stay in the ICU	In-hospital period after surgery (up to day 5)
Mechanical ventilation time	Duration of patient ventilator-assisted breathing	In-hospital period after surgery (up to day 5)

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: September 3, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 12, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: insulin resistance; diabetes mellitus; preoperative carbohydrates; off-pump coronary artery bypass grafting
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance
• Other Study ID Numbers: 2019-ZX40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Except for the identifying data such as patients name and admission ID, all the IPD could be available to other researchers on reasonable request.
• IPD Sharing Time Frame: The data will become available after the publication of the study report.
• IPD Sharing Access Criteria: IPD could be accessed on reasonable request after approval of the principal investigator.
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No