Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Effects of Pre-operative Oral Carbohydrates on Insulin Resistance and Postoperative Recovery in Diabetic Patients Undergoing Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05540249
• Other study ID #: 2019-ZX40
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: January 2023

Study information

• Verified date: September 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nausea or vomiting	Nausea or vomiting requiring medical treatment such as ondansetron	In-hospital period after surgery (up to day 5)
Other	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.	In-hospital period after surgery (up to day 5)
Other	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)
Other	ICU length	The length of patient's stay in the ICU	In-hospital period after surgery (up to day 5)
Other	Mechanical ventilation time	Duration of patient ventilator-assisted breathing	In-hospital period after surgery (up to day 5)
Primary	Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	Before anesthesia induction
Primary	Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	Immediately after surgery
Primary	Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	The first morning after surgery
Primary	Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	The second morning after surgery
Primary	Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	The third morning after surgery
Primary	Peri-operative Change from baseline HOMA-IR	HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5	The fifth morning after surgery
Secondary	Interleukin -1 (IL-1)	Inflammatory factors	The first morning after surgery
Secondary	Interleukin-6 (IL-6)	Inflammatory factors	The first morning after surgery
Secondary	Interleukin-8 (IL-8),	Inflammatory factors	The first morning after surgery
Secondary	Interleukin-10 (IL-10),	Inflammatory factors	The first morning after surgery
Secondary	Tumor necrosis fator-a (TNF-a)	Inflammatory factors	The first morning after surgery
Secondary	High-sensitivity C-reactive protein (hs-CRP)	Inflammatory factors	The first morning after surgery