Insulin Resistance, Diabetes Mellitus, Type 2, Coronary Artery Bypass Surgery
Conditions
Keywords
preoperative carbohydrates, diabetes mellitus, off-pump coronary artery bypass grafting, insulin resistance
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTcarbohydrates
Patients will orally consume 355mL CHO after 20:00 the evening before surgery.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
The surgeons, anesthesiologists, ICU staff, nurses, outcome assessors, data collectors and data analysts will be blinded to the grouping.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-operative Change from baseline HOMA-IR | Before anesthesia induction | HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 (IL-6) | The first morning after surgery | Inflammatory factors |
| Interleukin -1 (IL-1) | The first morning after surgery | Inflammatory factors |
| Interleukin-8 (IL-8), | The first morning after surgery | Inflammatory factors |
| Interleukin-10 (IL-10), | The first morning after surgery | Inflammatory factors |
| Tumor necrosis fator-α (TNF-α) | The first morning after surgery | Inflammatory factors |
| High-sensitivity C-reactive protein (hs-CRP) | The first morning after surgery | Inflammatory factors |
Other
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular and cerebral events (MACCEs) | In-hospital period after surgery (up to day 5) | A composite endpoints of all-cause death, non-fatal myocardial infarction, stroke. |
| ICU length | In-hospital period after surgery (up to day 5) | The length of patient's stay in the ICU |
| Mechanical ventilation time | In-hospital period after surgery (up to day 5) | Duration of patient ventilator-assisted breathing |
| New-onset postoperative atrial fibrillation (POAF) | In-hospital period after surgery (up to day 5) | 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. |
| Nausea or vomiting | In-hospital period after surgery (up to day 5) | Nausea or vomiting requiring medical treatment such as ondansetron |
Outcome results
None listed