Using branched-chain amino acids before surgery to reduce insulin resistance after colorectal cancer surgery.
A Multicenter Randomized Controlled Study of Preoperative Oral Administration of Branched-chain Amino Acids in Reducing Postoperative Insulin Resistance in Colorectal Cancer Patients
This study is testing if taking branched-chain amino acids before colorectal cancer surgery can help older patients manage their blood sugar better after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Tong Ren Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05494658 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of preoperative oral branched-chain amino acids (BCAAs) on reducing postoperative insulin resistance in patients undergoing elective laparoscopic radical resection for colorectal cancer. The study aims to determine if administering BCAAs before surgery can stabilize blood glucose levels and improve perioperative outcomes by mitigating the stress response associated with surgery. Participants will be monitored for changes in insulin resistance following the intervention. The trial is particularly focused on patients aged 50-80 with a clinical diagnosis of colorectal cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50-80 with a clinical diagnosis of colorectal cancer scheduled for elective laparoscopic surgery.
Not a fit: Patients with diabetes, preoperative insulin resistance, or severe organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved postoperative recovery and reduced complications for colorectal cancer patients.
How similar studies have performed: Previous studies in animal models have shown promising results with branched-chain amino acids in reducing insulin resistance, but this approach in humans is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Shanghai Tongren Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Peng Sun, MD
- Email: SP2082@shtrhospital.com
- Phone: +86-18121225835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.