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

Sponsor
Shanghai Tong Ren Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05494658
Collaborator
(none)
224
Enrollment
2
Arms
18.7
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: BCAA
  • Dietary Supplement: water
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 10, 2022
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Mar 2, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: research group

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

Dietary Supplement: BCAA
600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
Placebo Comparator: control group

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Postoperative blood glucose [1 day]

    Measured by continuous blood glucose meter

  2. 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.

  3. 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

  4. Postoperative hospital stay [1 month]

    Postoperative hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Tong Ren Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Tong Ren Hospital
ClinicalTrials.gov Identifier:
NCT05494658
Other Study ID Numbers:
  • 2022-050-01
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 16, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Tong Ren Hospital
postoperative insulin resistance
branched chain amino acids
colorectal cancer
Additional relevant MeSH terms:
Colorectal Neoplasms
Insulin Resistance

Study Results

No Results Posted as of Aug 16, 2022