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

NCT ID: NCT05494658

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-26

Study Completion Date

2024-12-31

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.

Detailed Description

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Conditions

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Insulin Resistance Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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research group

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

Group Type EXPERIMENTAL

BCAA

Intervention Type DIETARY_SUPPLEMENT

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

control group

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

Group Type PLACEBO_COMPARATOR

water

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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BCAA

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

Intervention Type DIETARY_SUPPLEMENT

water

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role collaborator

Yangpu District Central Hospital Affiliated to Tongji University

OTHER

Sponsor Role collaborator

Sun Peng

OTHER

Sponsor Role lead

Responsible Party

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Sun Peng

Executive Director of General Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shanghai Tongren Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng Sun, MD

Role: CONTACT

+86-18121225835

Hengyu Lv

Role: CONTACT

+86-18006315921

Facility Contacts

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Peng Sun

Role: primary

+86-18121225835

Other Identifiers

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2022-050-01

Identifier Type: -

Identifier Source: org_study_id

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