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

Not Applicable

Recruiting

• Conditions: Insulin Resistance; Colorectal Cancer

• Registration Number: NCT05494658
• Lead Sponsor: Sun Peng

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-26
• Study First Submitted QC: 2022-08-07
• Study First Posted: 2022-08-10
• Study Start: 2022-08-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 224

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of postoperative blood glucose>8mmol/L	1 day	The proportion of postoperative blood glucose\>8mmol/L.Measure method：Continuous blood glucose meter.

Secondary Outcome Measures

Name	Time	Method
Postoperative blood glucose	1 day	Measured by continuous blood glucose meter
Homeostasis model assessment - insulin resistance （HOMA-IR）	1 day	Measured by blood test. HOMA-IR = (blood glucose \[mmol/L\] × blood insulin \[μunits/mL\])/22.5.
Postoperative complications	1 month	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
Postoperative hospital stay	1 month	Postoperative hospital stay

Trial Locations

Locations (1)

Shanghai Tongren Hospital; 🇨🇳 Shanghai, China