Pre-operative Carbohydrates in Diabetic Patients Undergoing CABG

NCT05540249 | Unknown DMC

• 1 other identifier: 2019-ZX40
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

preoperative carbohydrates; diabetes mellitus; off-pump coronary artery bypass grafting; insulin resistance

Outcome Measures

Primary Outcomes (6)

• Peri-operative Change from baseline HOMA-IR

  HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5

  Before anesthesia induction

• Peri-operative Change from baseline HOMA-IR

  HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5

  Immediately after surgery

• Peri-operative Change from baseline HOMA-IR

  HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5

  The first morning after surgery

• Peri-operative Change from baseline HOMA-IR

  HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5

  The second morning after surgery

• Peri-operative Change from baseline HOMA-IR

  HOMA-IR = \[blood insulin (mu/L) × Blood glucose (mmol/L)\]/22.5

  The third morning after surgery

• 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 Outcomes (6)

• Interleukin -1 (IL-1)

  The first morning after surgery

• Interleukin-6 (IL-6)

  The first morning after surgery

• Interleukin-8 (IL-8),

  The first morning after surgery

• Interleukin-10 (IL-10),

  The first morning after surgery

• Tumor necrosis fator-α (TNF-α)

  The first morning after surgery

Other Outcomes (5)

• Nausea or vomiting

  In-hospital period after surgery (up to day 5)

• New-onset postoperative atrial fibrillation (POAF)

  In-hospital period after surgery (up to day 5)

• Major adverse cardiovascular and cerebral events (MACCEs)

  In-hospital period after surgery (up to day 5)

Study Arms (2)

Group CHO

EXPERIMENTAL

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).

Dietary Supplement: carbohydrates

Group CTRL

NO INTERVENTION

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

Interventions

carbohydrates DIETARY_SUPPLEMENT

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

Also known as: Outfast

Group CHO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

MeSH Terms

Conditions

Insulin Resistance; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The surgeons, anesthesiologists, ICU staff, nurses, outcome assessors, data collectors and data analysts will be blinded to the grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 14, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The data will become available after the publication of the study report.
• Access Criteria: IPD could be accessed on reasonable request after approval of the principal investigator.