Back to resultsImpact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.
Primary Purpose
Insulin Resistance, Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BCAA
water
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring postoperative insulin resistance, branched chain amino acids, colorectal cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Shanghai Tongren HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
research group
control group
Arm Description
600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
600ml water was consumed by patients 2-4h before suegery.
Outcomes
Primary Outcome Measures
The proportion of postoperative blood glucose>8mmol/L
The proportion of postoperative blood glucose>8mmol/L.Measure method：Continuous blood glucose meter.
Secondary Outcome Measures
Postoperative blood glucose
Measured by continuous blood glucose meter
Homeostasis model assessment - insulin resistance （HOMA-IR）
Measured by blood test. HOMA-IR = (blood glucose [mmol/L] × blood insulin [μunits/mL])/22.5.
Postoperative complications
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
Postoperative hospital stay
Postoperative hospital stay
Full Information
NCT ID
NCT05494658
First Posted
July 26, 2022
Last Updated
September 4, 2022
Sponsor
Sun Peng
Collaborators
Huashan Hospital, Yangpu District Central Hospital Affiliated to Tongji University
1. Study Identification
Unique Protocol Identification Number
NCT05494658
Brief Title
Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sun Peng
Collaborators
Huashan Hospital, Yangpu District Central Hospital Affiliated to Tongji University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Colorectal Cancer
Keywords
postoperative insulin resistance, branched chain amino acids, colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
research group
Arm Type
Experimental
Arm Description
600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
600ml water was consumed by patients 2-4h before suegery.
Intervention Type
Dietary Supplement
Intervention Name(s)
BCAA
Intervention Description
600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
Intervention Type
Dietary Supplement
Intervention Name(s)
water
Intervention Description
600ml water was consumed by patients 2-4h before suegery.
Primary Outcome Measure Information:
Title
The proportion of postoperative blood glucose>8mmol/L
Description
The proportion of postoperative blood glucose>8mmol/L.Measure method：Continuous blood glucose meter.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Postoperative blood glucose
Description
Measured by continuous blood glucose meter
Time Frame
1 day
Title
Homeostasis model assessment - insulin resistance （HOMA-IR）
Description
Measured by blood test. HOMA-IR = (blood glucose [mmol/L] × blood insulin [μunits/mL])/22.5.
Time Frame
1 day
Title
Postoperative complications
Description
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
Time Frame
1 month
Title
Postoperative hospital stay
Description
Postoperative hospital stay
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Sun, MD
Phone
+86-18121225835
Email
SP2082@shtrhospital.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hengyu Lv
Phone
+86-18006315921
Email
LHY4624@shtrhospital.com
Facility Information:
Facility Name
Shanghai Tongren Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Sun
Phone
+86-18121225835
Email
SP2082@shtrhospital.com
12. IPD Sharing Statement
Learn more about this trial
Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.
We'll reach out to this number within 24 hrs