Insulin ResistanceNCT05494658
Impact of Preoperative Oral Branched-chain Amino Acids on Reducing Postoperative Insulin Resistance.
A study testing BCAA and water in people with Insulin Resistance and Colorectal Cancer, run by Sun Peng at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Insulin Resistance, Colorectal Cancer
- What is being tested?
- BCAA and water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2022to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- BCAA, water
- Keywords
- postoperative insulin resistance, branched chain amino acids, colorectal cancer
- Medical subject headings
- Insulin Resistance, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCAADietary supplement
600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery.
waterDietary supplement
600ml water was consumed by patients 2-4h before suegery.
| Study group | Role | What they receive |
|---|---|---|
| research group | Experimental | 600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery. Receives: Dietary Supplement: BCAA |
| control group | Placebo comparator | 600ml water was consumed by patients 2-4h before suegery. Receives: Dietary Supplement: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of postoperative blood glucose>8mmol/L
The proportion of postoperative blood glucose>8mmol/L.Measure method：Continuous blood glucose meter.
Measured: 1 day
Secondary outcomes (4)
Postoperative blood glucose
Measured by continuous blood glucose meter
Measured: 1 day
Homeostasis model assessment - insulin resistance （HOMA-IR）
Measured by blood test. HOMA-IR = (blood glucose [mmol/L] × blood insulin [μunits/mL])/22.5.
Measured: 1 day
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
Measured: 1 month
Postoperative hospital stay
Postoperative hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start26 Aug 2022
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Why it stopped: The mid-term analysis of the study showed no significant difference between the two groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Peng
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Yangpu District Central Hospital Affiliated to Tongji University
- Responsible party
- Sponsor-investigator, Sun Peng, Shanghai Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494658
- Sponsor's protocol ID
- 2022-050-01
- Status last verified
- Mar 2024
- First submitted
- 26 Jul 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05494658
- Acronym / sponsor ID
- 2022-050-01
- Conditions
- Insulin Resistance, Colorectal Cancer
- Keywords
- postoperative insulin resistance, branched chain amino acids, colorectal cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The mid-term analysis of the study showed no significant difference between the two groups.
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Sun PengUniversity, hospital or other
- Collaborators
- Huashan Hospital, Yangpu District Central Hospital Affiliated to Tongji University
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| research group | Experimental | Dietary Supplement: BCAA600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery. |
| control group | Placebo comparator | Dietary Supplement: water600ml water was consumed by patients 2-4h before suegery. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCAA600ml drink which contains 18g BCAA was consumed by patients 2-4h before surgery. | Dietary supplement | research group |
| water600ml water was consumed by patients 2-4h before suegery. | Dietary supplement | control group |
Primary outcome
The proportion of postoperative blood glucose>8mmol/L
Time frame: 1 day
The proportion of postoperative blood glucose>8mmol/L.Measure method：Continuous blood glucose meter.
4 secondary outcomes
Postoperative blood glucose
Time frame: 1 day
Homeostasis model assessment - insulin resistance （HOMA-IR）
Time frame: 1 day
Postoperative complications
Time frame: 1 month
Postoperative hospital stay
Time frame: 1 month
Results and safety
The study was stopped early (reason given: The mid-term analysis of the study showed no significant difference between the two groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCAA and water in people with Insulin Resistance and Colorectal Cancer, run by Sun Peng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The mid-term analysis of the study showed no significant difference between the two groups.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of postoperative blood glucose>8mmol/L (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.