Insulin ResistanceNCT01819688
Surgical Stress After Laparoscopic Compared to Open Liver Resection
A study testing laparoscopic liver resection in people with Insulin Resistance, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the postoperative insulin resistance and cytokine release would be attenuated in laparoscopic compared with open liver resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- laparoscopic liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- Aug 2007to Nov 2008
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-2
- left hemihepatectomy(liver resection)
- left lateral sectionectomy(liver resection)
Who cannot join
- Patients with diabetes mellitus
- drug abuse
- BMI >24 or <18
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016
About this study
Official title: Surgical Stress Induced Insulin Resistance and Cytokine Response After Laparoscopic Compared to Open Liver Resection
The purpose of this study is to determine whether the postoperative insulin resistance and cytokine release would be attenuated in laparoscopic compared with open liver resection.
- Conditions
- Insulin Resistance
- Being tested
- laparoscopic liver resection
- Keywords
- laparoscopic liver resection, cytokine release
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic liver resectionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative insulin resistance calculated by serum insulin and blood glucose
At baseline prior to surgery, and 3hr, 12hr, 24hr, 72hrs after operation, blood glucose and insulin was measured.
Insulin resistance is assessed by the HOMAIR(homeostatic model assessment of insulin resistance) score which is calculated through the mathematic formula: HOMAIR= FI ×FG/22.5, where FI= fasting serum insulin(μU/mL), FG= fasting plasma glucose (mmol/L), and 22.5 is a constant.
Measured: within the first 72hrs after operation
Secondary outcomes (1)
cytokine changement including IL-1β, IFN-γ, IL-4 and IL-10 before and after operation
At baseline before operation and 0, 3hr, 12hr, 24hr, D3, D5 after operation, duplicated samples were drawn to analyze serum IL-1β, IFN-γ, IL-4 and IL-10.
Measured: within 5 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startAug 2007
- Primary completionNov 2008
- Study completionNov 2008
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.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-Yan Yan, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819688
- Sponsor's protocol ID
- 20120704
- Other IDs
- (1)2009R50040 (2)LY12H02005
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 27 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Stress Induced Insulin Resistance and Cytokine Response After Laparoscopic Compared to Open Liver Resection
- ClinicalTrials.gov ID
- NCT01819688
- Acronym / sponsor ID
- 20120704
- Conditions
- Insulin Resistance
- Keywords
- laparoscopic liver resection, cytokine release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 27 Mar 2013 (estimated)
- 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.
The purpose of this study is to determine whether the postoperative insulin resistance and cytokine release would be attenuated in laparoscopic compared with open liver resection.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-2
- left hemihepatectomy(liver resection)
- left lateral sectionectomy(liver resection)
Key exclusion criteria (3 listed)
- Patients with diabetes mellitus
- drug abuse
- BMI >24 or <18
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 |
|---|---|---|
| laparoscopic liver resection | Procedure or surgery | – |
Primary outcome
postoperative insulin resistance calculated by serum insulin and blood glucose
Time frame: within the first 72hrs after operation
At baseline prior to surgery, and 3hr, 12hr, 24hr, 72hrs after operation, blood glucose and insulin was measured. Insulin resistance is assessed by the HOMAIR(homeostatic model assessment of insulin resistance) score which is calculated through the mathematic formula: HOMAIR= FI ×FG/22.5, where FI= fasting serum insulin(μU/mL), FG= fasting plasma glucose (mmol/L), and 22.5 is a constant.
1 secondary outcome
cytokine changement including IL-1β, IFN-γ, IL-4 and IL-10 before and after operation
Time frame: within 5 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2013.
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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 laparoscopic liver resection in people with Insulin Resistance, run by Sir Run Run Shaw Hospital 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Mar 2013. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative insulin resistance calculated by serum insulin and blood glucose (time frame: within the first 72hrs after operation). 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 27 Mar 2013.