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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494658
• Other study ID #: 2022-050-01
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Shanghai Tong Ren Hospital
• Contact: Peng Sun, MD
• Phone: +86-18121225835
• Email: SP2082[@]shtrhospital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Insulin Resistance

Intervention

Dietary Supplement:
• BCAA
600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
• water
600ml water was consumed by patients 2-4h before suegery.

Locations

Country	Name	City	State
China	Shanghai Tongren Hospital	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Sun Peng	Huashan Hospital, Yangpu District Central Hospital Affiliated to Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative blood glucose	Measured by continuous blood glucose meter	1 day
Secondary	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
Secondary	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
Secondary	Postoperative hospital stay	Postoperative hospital stay	1 month