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Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.
Study Purpose
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.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
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.Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: research group
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.
Interventions
Dietary Supplement: - BCAA
600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
Dietary Supplement: - water
600ml water was consumed by patients 2-4h before suegery.
Contact a Trial Team
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International Sites
Status
Recruiting
Address
Shanghai Tongren Hospital
Shanghai, ,
Site Contact
Peng Sun
[email protected]
+86-18121225835
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