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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

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05494658
Enrollment
79
Registered
2022-08-10
Start date
2022-08-26
Completion date
2024-12-20
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Insulin Resistance

Keywords

postoperative insulin resistance, branched chain amino acids, colorectal cancer

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.

Interventions

DIETARY_SUPPLEMENTBCAA

600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.

DIETARY_SUPPLEMENTwater

600ml water was consumed by patients 2-4h before suegery.

Sponsors

Sun Peng
Lead SponsorOTHER
Huashan Hospital
CollaboratorOTHER
Yangpu District Central Hospital Affiliated to Tongji University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The proportion of postoperative blood glucose>8mmol/L1 dayThe proportion of postoperative blood glucose\>8mmol/L.Measure method:Continuous blood glucose meter.

Secondary

MeasureTime frameDescription
Postoperative blood glucose1 dayMeasured by continuous blood glucose meter
Homeostasis model assessment - insulin resistance (HOMA-IR)1 dayMeasured by blood test. HOMA-IR = (blood glucose \[mmol/L\] × blood insulin \[μunits/mL\])/22.5.
Postoperative complications1 monthPostoperative 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 stay1 monthPostoperative hospital stay

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026