Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG

National Center for Cardiovascular Diseases

Status: Not yet enrolling

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

Treatments: Dietary Supplement: carbohydrates

Study type: Interventional

Funder types: Other

Identifiers

NCT05540249

2019-ZX40

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 2 patient groups

Group CHO

Experimental group

Description:

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).

Treatment:

Dietary Supplement: carbohydrates

Group CTRL

No Intervention group

Description:

Patients in Group CTRL will consume no food or drink 12 hours before operation (20:00 the evening before operation).