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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group CHO | Experimental | 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). |
|
| Group CTRL | No Intervention | Patients in Group CTRL will consume no food or drink 12 hours before operation (20:00 the evening before operation). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbohydrates | Dietary Supplement | Patients will orally consume 355mL CHO after 20:00 the evening before surgery. |
|
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Except for the identifying data such as patients name and admission ID, all the IPD could be available to other researchers on reasonable request.
The data will become available after the publication of the study report.
IPD could be accessed on reasonable request after approval of the principal investigator.
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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The surgeons, anesthesiologists, ICU staff, nurses, outcome assessors, data collectors and data analysts will be blinded to the grouping.
| 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 |
| 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) |
| D004700 | Endocrine System Diseases |