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

NCT05494658 | Recruiting DMC

• 1 other identifier: 2022-050-01
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulin Resistance; Colorectal Cancer

Keywords

postoperative insulin resistance; branched chain amino acids; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative blood glucose

  1 day

• Homeostasis model assessment - insulin resistance （HOMA-IR）

  1 day

• Postoperative complications

  1 month

• Postoperative hospital stay

  1 month

Study Arms (2)

research group

EXPERIMENTAL

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

Dietary Supplement: BCAA

control group

PLACEBO COMPARATOR

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

Dietary Supplement: water

Interventions

BCAA DIETARY_SUPPLEMENT

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

research group

water DIETARY_SUPPLEMENT

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

control group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Peng: lead
• Huashan Hospital: collaborator
• Yangpu District Central Hospital Affiliated to Tongji University: collaborator

Study Sites (1)

Shanghai Tongren Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Insulin Resistance; Colorectal Neoplasms

Interventions

Water

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Central Study Contacts

Peng Sun, MD

CONTACT

+86-18121225835; SP2082@shtrhospital.com

Hengyu Lv

CONTACT

+86-18006315921; LHY4624@shtrhospital.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director of General Surgery

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 10, 2022
• Study Start: August 26, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

CN (1)