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Trial Title:
Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.
NCT ID:
NCT05494658
Condition:
Insulin Resistance
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Insulin Resistance
Conditions: Keywords:
postoperative insulin resistance
branched chain amino acids
colorectal cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
BCAA
Description:
600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
Arm group label:
research group
Intervention type:
Dietary Supplement
Intervention name:
water
Description:
600ml water was consumed by patients 2-4h before suegery.
Arm group label:
control group
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Tongren Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Peng Sun
Phone:
+86-18121225835
Email:
SP2082@shtrhospital.com
Start date:
August 26, 2022
Completion date:
December 2024
Lead sponsor:
Agency:
Sun Peng
Agency class:
Other
Collaborator:
Agency:
Huashan Hospital
Agency class:
Other
Collaborator:
Agency:
Yangpu District Central Hospital Affiliated to Tongji University
Agency class:
Other
Source:
Shanghai Tong Ren Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05494658
