Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG
Primary Purpose
Insulin Resistance, Diabetes Mellitus, Type 2, Coronary Artery Bypass Surgery
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
carbohydrates
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring preoperative carbohydrates, diabetes mellitus, off-pump coronary artery bypass grafting, insulin resistance
Eligibility Criteria
Inclusion Criteria:
- Previously diagnosed T2DM
- Diagnosed with CAD with coronary angiography and indicated for OPCAB
- Age between 18 and 75 years old
- First operation in the morning and anesthesia induced around 8:00
- Written informed consent by the patients
Exclusion Criteria:
- Combined with other heart diseases or vascular malformations that require surgery in addition to OPCAB
- Presence of symptoms or signs of heart failure such as orthopnea, distended jugular vein, lower extremity edema, etc.
- Reduced LVEF (lower than 50%)
- Combined with gastroesophageal reflux
- Combined with thyroid insufficiency requiring replacement therapy with levothyroxine
- Combined with adrenal insufficiency requiring replacement therapy with corticosteroids
- Refuse to participate.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group CHO
Group CTRL
Arm 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).
Patients in Group CTRL will consume no food or drink 12 hours before operation (20:00 the evening before operation).
Outcomes
Primary Outcome Measures
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Peri-operative Change from baseline HOMA-IR
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Secondary Outcome Measures
Interleukin -1 (IL-1)
Inflammatory factors
Interleukin-6 (IL-6)
Inflammatory factors
Interleukin-8 (IL-8),
Inflammatory factors
Interleukin-10 (IL-10),
Inflammatory factors
Tumor necrosis fator-α (TNF-α)
Inflammatory factors
High-sensitivity C-reactive protein (hs-CRP)
Inflammatory factors
Full Information
NCT ID
NCT05540249
First Posted
September 3, 2022
Last Updated
September 12, 2022
Sponsor
China National Center for Cardiovascular Diseases
1. Study Identification
Unique Protocol Identification Number
NCT05540249
Brief Title
Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG
Official Title
Effects of Pre-operative Oral Carbohydrates on Insulin Resistance and Postoperative Recovery in Diabetic Patients Undergoing Coronary Artery Bypass Grafting
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Diabetes Mellitus, Type 2, Coronary Artery Bypass Surgery
Keywords
preoperative carbohydrates, diabetes mellitus, off-pump coronary artery bypass grafting, insulin resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The surgeons, anesthesiologists, ICU staff, nurses, outcome assessors, data collectors and data analysts will be blinded to the grouping.
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group CHO
Arm Type
Experimental
Arm 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).
Arm Title
Group CTRL
Arm Type
No Intervention
Arm Description
Patients in Group CTRL will consume no food or drink 12 hours before operation (20:00 the evening before operation).
Intervention Type
Dietary Supplement
Intervention Name(s)
carbohydrates
Other Intervention Name(s)
Outfast
Intervention Description
Patients will orally consume 355mL CHO after 20:00 the evening before surgery.
Primary Outcome Measure Information:
Title
Peri-operative Change from baseline HOMA-IR
Description
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Time Frame
Before anesthesia induction
Title
Peri-operative Change from baseline HOMA-IR
Description
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Time Frame
Immediately after surgery
Title
Peri-operative Change from baseline HOMA-IR
Description
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Time Frame
The first morning after surgery
Title
Peri-operative Change from baseline HOMA-IR
Description
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Time Frame
The second morning after surgery
Title
Peri-operative Change from baseline HOMA-IR
Description
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Time Frame
The third morning after surgery
Title
Peri-operative Change from baseline HOMA-IR
Description
HOMA-IR = [blood insulin (mu/L) × Blood glucose (mmol/L)]/22.5
Time Frame
The fifth morning after surgery
Secondary Outcome Measure Information:
Title
Interleukin -1 (IL-1)
Description
Inflammatory factors
Time Frame
The first morning after surgery
Title
Interleukin-6 (IL-6)
Description
Inflammatory factors
Time Frame
The first morning after surgery
Title
Interleukin-8 (IL-8),
Description
Inflammatory factors
Time Frame
The first morning after surgery
Title
Interleukin-10 (IL-10),
Description
Inflammatory factors
Time Frame
The first morning after surgery
Title
Tumor necrosis fator-α (TNF-α)
Description
Inflammatory factors
Time Frame
The first morning after surgery
Title
High-sensitivity C-reactive protein (hs-CRP)
Description
Inflammatory factors
Time Frame
The first morning after surgery
Other Pre-specified Outcome Measures:
Title
Nausea or vomiting
Description
Nausea or vomiting requiring medical treatment such as ondansetron
Time Frame
In-hospital period after surgery (up to day 5)
Title
New-onset postoperative atrial fibrillation (POAF)
Description
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.
Time Frame
In-hospital period after surgery (up to day 5)
Title
Major adverse cardiovascular and cerebral events (MACCEs)
Description
A composite endpoints of all-cause death, non-fatal myocardial infarction, stroke.
Time Frame
In-hospital period after surgery (up to day 5)
Title
ICU length
Description
The length of patient's stay in the ICU
Time Frame
In-hospital period after surgery (up to day 5)
Title
Mechanical ventilation time
Description
Duration of patient ventilator-assisted breathing
Time Frame
In-hospital period after surgery (up to day 5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previously diagnosed T2DM
Diagnosed with CAD with coronary angiography and indicated for OPCAB
Age between 18 and 75 years old
First operation in the morning and anesthesia induced around 8:00
Written informed consent by the patients
Exclusion Criteria:
Combined with other heart diseases or vascular malformations that require surgery in addition to OPCAB
Presence of symptoms or signs of heart failure such as orthopnea, distended jugular vein, lower extremity edema, etc.
Reduced LVEF (lower than 50%)
Combined with gastroesophageal reflux
Combined with thyroid insufficiency requiring replacement therapy with levothyroxine
Combined with adrenal insufficiency requiring replacement therapy with corticosteroids
Refuse to participate.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Except for the identifying data such as patients name and admission ID, all the IPD could be available to other researchers on reasonable request.
IPD Sharing Time Frame
The data will become available after the publication of the study report.
IPD Sharing Access Criteria
IPD could be accessed on reasonable request after approval of the principal investigator.
Learn more about this trial
Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG
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