Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.

A Multicenter Randomized Controlled Study of Preoperative Oral Administration of Branched-chain Amino Acids in Reducing Postoperative Insulin Resistance in Colorectal Cancer Patients

Postoperative insulin resistance refers to the phenomenon that the body's glucose uptake stimulated by insulin is reduced due to stress effects such as trauma or the inhibitory effect of insulin on liver glucose output is weakened after surgery.

There is a clear link between postoperative insulin resistance and poor perioperative prognosis. Therefore, exploring interventions to reduce postoperative stress insulin resistance, stabilize postoperative blood glucose, and reduce postoperative complications are clinical problems that need to be solved urgently. In recent years, research on branched-chain amino acids and metabolic diseases has become a hot spot. Studies have found that in the rat model, preoperatively given a high branched-chain amino acid diet can inhibit postoperative insulin resistance and stabilize blood glucose levels. This research plan is to try to add branched-chain amino acids before surgery to observe the occurrence of postoperative insulin resistance in patients.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Insulin Resistance
• Intervention / Treatment: Dietary supplement: BCAA; Dietary supplement: water

• Study Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peng Sun, MD; Phone Number: +86-18121225835; Email: SP2082@shtrhospital.com
• Study Contact Backup: Name: Hengyu Lv; Phone Number: +86-18006315921; Email: LHY4624@shtrhospital.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Tongren Hospital
    • Contact: Peng Sun; Phone Number: +86-18121225835; Email: SP2082@shtrhospital.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 50-80 years old ;
2. Clinical diagnosis of colorectal cancer;
3. Planned elective laparoscopic radical resection of colorectal cancer;
4. Preoperative American Society of Anesthesiologists（ASA）score grade I-III ;
5. Informed consent was obtained from patients.

Exclusion Criteria:

1. Clinical diagnosis of Diabetes mellitus;
2. Preoperative insulin resistance ;
3. Renal insufficiency requires dialysis, hepatic insufficiency (Child - Pugh grade B and above);
4. Eating disorders caused by gastrointestinal obstruction;
5. Pregnant or lactating women;
6. Patients with severe mental illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: research group; 600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.	Dietary supplement: BCAA; 600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
Placebo Comparator: control group; 600ml water was consumed by patients 2-4h before suegery.	Dietary supplement: water; 600ml water was consumed by patients 2-4h before suegery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of postoperative blood glucose>8mmol/L	The proportion of postoperative blood glucose>8mmol/L.Measure method：Continuous blood glucose meter.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hospital stay	Postoperative hospital stay	1 month
Postoperative blood glucose	Measured by continuous blood glucose meter	1 day
Homeostasis model assessment - insulin resistance （HOMA-IR）	Measured by blood test. HOMA-IR = (blood glucose [mmol/L] × blood insulin [μunits/mL])/22.5.	1 day
Postoperative complications	Postoperative complications include branched-chain amino acid-related complications, surgery-related complications, and systemic complications. Postoperative complications were graded according to the Clavien-Dindo system	1 month

Collaborators and Investigators

• Sponsor: Sun Peng
• Collaborators: Huashan Hospital; Yangpu District Central Hospital Affiliated to Tongji University

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 7, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: colorectal cancer; branched chain amino acids; postoperative insulin resistance
• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Hyperinsulinism; Colorectal Neoplasms; Insulin Resistance
• Other Study ID Numbers: 2022-050-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No