Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Insulin Resistance, Diabetes Mellitus, Type 2, Coronary Artery Bypass Surgery

Intervention / Treatment
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* Dietary Supplement: carbohydrates


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously diagnosed T2DM Diagnosed with CAD with coronary angiography and indicated for OPCAB Age between 18 and 75 years old First operation in the morning and anesthesia induced around 8:00 Written informed consent by the patients Exclusion Criteria: Combined with other heart diseases or vascular malformations that require surgery in addition to OPCAB Presence of symptoms or signs of heart failure such as orthopnea, distended jugular vein, lower extremity edema, etc. Reduced LVEF (lower than 50%) Combined with gastroesophageal reflux Combined with thyroid insufficiency requiring replacement therapy with levothyroxine Combined with adrenal insufficiency requiring replacement therapy with corticosteroids Refuse to participate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group CHO<br>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<br>* Patients will orally consume 355mL CHO after 20:00 the evening before surgery.<br>* Other names: Outfast;|
| No Intervention: Group CTRL<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative carbohydrates, diabetes mellitus, off-pump coronary artery bypass grafting, insulin resistance