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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
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    September 3, 2022
    Last Updated
    September 12, 2022
    Sponsor
    China National Center for Cardiovascular Diseases
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    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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