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

Study Overview
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Brief Summary
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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.

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

Conditions
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Insulin Resistance, Colorectal Cancer

Intervention / Treatment
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* Dietary Supplement: BCAA
* Dietary Supplement: water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50-80 years old ; Clinical diagnosis of colorectal cancer; Planned elective laparoscopic radical resection of colorectal cancer; Preoperative American Society of Anesthesiologists（ASA）score grade I-III ; Informed consent was obtained from patients. Exclusion Criteria: Clinical diagnosis of Diabetes mellitus; Preoperative insulin resistance ; Renal insufficiency requires dialysis, hepatic insufficiency (Child - Pugh grade B and above); Eating disorders caused by gastrointestinal obstruction; Pregnant or lactating women; Patients with severe mental illness.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 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 | 
| Postoperative hospital stay | Postoperative hospital stay | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postoperative insulin resistance, branched chain amino acids, colorectal cancer