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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
62
Patients will orally consume 355mL CHO after 20:00 the evening before surgery.
Peri-operative Change from baseline HOMA-IR
HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5
Time frame: Before anesthesia induction
Peri-operative Change from baseline HOMA-IR
HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5
Time frame: Immediately after surgery
Peri-operative Change from baseline HOMA-IR
HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5
Time frame: The first morning after surgery
Peri-operative Change from baseline HOMA-IR
HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5
Time frame: The second morning after surgery
Peri-operative Change from baseline HOMA-IR
HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5
Time frame: The third morning after surgery
Peri-operative Change from baseline HOMA-IR
HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5
Time frame: The fifth morning after surgery
Interleukin -1 (IL-1)
Inflammatory factors
Time frame: The first morning after surgery
Interleukin-6 (IL-6)
Inflammatory factors
Time frame: The first morning after surgery
Interleukin-8 (IL-8),
Inflammatory factors
Time frame: The first morning after surgery
Interleukin-10 (IL-10),
Inflammatory factors
Time frame: The first morning after surgery
Tumor necrosis fator-α (TNF-α)
Inflammatory factors
Time frame: The first morning after surgery
High-sensitivity C-reactive protein (hs-CRP)
Inflammatory factors
Time frame: The first morning after surgery
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