Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-01-31

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.

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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.

Conditions

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Insulin Resistance Diabetes Mellitus, Type 2 Coronary Artery Bypass Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

The surgeons, anesthesiologists, ICU staff, nurses, outcome assessors, data collectors and data analysts will be blinded to the grouping.

Study Groups

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Group CHO

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 Type EXPERIMENTAL

carbohydrates

Intervention Type DIETARY_SUPPLEMENT

Patients will orally consume 355mL CHO after 20:00 the evening before surgery.

Group CTRL

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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carbohydrates

Patients will orally consume 355mL CHO after 20:00 the evening before surgery.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Outfast

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No