Coronary Artery Occlusive DisseaseNCT02330263
Effect of Preoperative Oral Carbohydrates on Postoperative Insulin Resistance in Patients Undergoing OPCAB(Off- Pump Coronary Artery Bypass Surgery)
A study testing carbohydrate beverage in people with Coronary Artery Occlusive Dissease, run by Yonsei University at 1 site in South Korea.
Trial summary
Surgical stress creates a state of insulin resistance which has been related to increased postoperative complications. Fasting before surgery induces a catabolic state that contributes to the development of insulin resistance. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Coronary Artery Occlusive Dissease
- What is being tested?
- carbohydrate beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Jul 2016
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are scheduled to undergo OPCAB
Who cannot join
- Subjects are ineligible if they have DM(Diabetes Mellitus),
- Gastroesophageal reflux disease or gastric emptying disorder,
- inflammatory bowel disease,
- previous treatment for intra-abdominal cancer,
- entered surgery more than 5 hours after ingestion of the morning carbohydrate beverage,
- cognitive dysfunction,
- disabling mental change disorder,
- are unable to communicate or speak Korean
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Seoul, 120-752
About this study
Surgical stress creates a state of insulin resistance which has been related to increased postoperative complications. Fasting before surgery induces a catabolic state that contributes to the development of insulin resistance. The aim of this study is to evaluate the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79 years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before surgery and in the morning of the operation day (3 hours before their scheduled operation). In contrast, patients in the control group consume no food or drink after midnight before their surgery. The primary endpoints are postoperative insulin resistance measured by short insulin tolerance test.
- Conditions
- Coronary Artery Occlusive Dissease
- Being tested
- carbohydrate beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbohydrate beverageDietary supplement
400ml of 12.8 g/100 ml carbohydrate beverage
| Study group | Role | What they receive |
|---|---|---|
| carbohydrate group | Experimental | Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before their surgery and in the morning of the operation day (3 hours before their scheduled operation). Receives: Dietary Supplement: carbohydrate beverage |
| control group | No intervention | Patients in the control group consume no food or drink after midnight before surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative insulin resistance
Measured: within 1 hour after surgery
Secondary outcomes (3)
preoperative discomfort
the preoperative discomfort measured by VAS (Visual Analog Scale)
Measured: 24 hours
perioperative hemodynamic effect
perioperative hemodynamic effect measured by amount of used vasopressors and minimum mixed venous oxygen saturation
Measured: 24 hours
postoperative complications
infection, Myocardiac infarction, Acute renal failure, re-operation, death, etc
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Occlusive DisseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330263
- Sponsor's protocol ID
- 4-2014-0908
- Status last verified
- Aug 2016
- First submitted
- 29 Dec 2014
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee B, Soh S, Shim JK, Kim HY, Lee H, Kwak YL. Evaluation of preoperative oral carbohydrate administration on insulin resistance in off-pump coronary artery bypass patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):740-747. doi: 10.1097/EJA.0000000000000637.
PubMed 28437263
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Carbohydrates on Postoperative Insulin Resistance in Patients Undergoing OPCAB(Off- Pump Coronary Artery Bypass Surgery)
- ClinicalTrials.gov ID
- NCT02330263
- Acronym / sponsor ID
- 4-2014-0908
- Conditions
- Coronary Artery Occlusive Dissease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Jan 2015 (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.
Surgical stress creates a state of insulin resistance which has been related to increased postoperative complications. Fasting before surgery induces a catabolic state that contributes to the development of insulin resistance. The aim of this study is to evaluate the effect of preoperative oral carbohydrates on postoperative insulin resistance in patients undergoing OPCAB (off-pump coronary artery bypass surgery). Sixty patients, aged 20 to 79 years, scheduled for OPCAB will be divided into carbohydrate (n=30) and control (n=30) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before surgery and in the morning of the operation day (3 hours before their scheduled operation). In contrast, patients in the control group consume no food or drink after midnight before their surgery. The primary endpoints are postoperative insulin resistance measured by short insulin tolerance test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carbohydrate group | Experimental | Dietary Supplement: carbohydrate beverageRandomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage in the evening before their surgery and in the morning of the operation day (3 hours before their scheduled operation). |
| control group | No intervention | –Patients in the control group consume no food or drink after midnight before surgery. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who are scheduled to undergo OPCAB
Key exclusion criteria (8 listed)
- Subjects are ineligible if they have DM(Diabetes Mellitus),
- Gastroesophageal reflux disease or gastric emptying disorder,
- inflammatory bowel disease,
- previous treatment for intra-abdominal cancer,
- entered surgery more than 5 hours after ingestion of the morning carbohydrate beverage,
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 |
|---|---|---|
| carbohydrate beverage400ml of 12.8 g/100 ml carbohydrate beverage | Dietary supplement | carbohydrate group |
Primary outcome
postoperative insulin resistance
Time frame: within 1 hour after surgery
3 secondary outcomes
preoperative discomfort
Time frame: 24 hours
perioperative hemodynamic effect
Time frame: 24 hours
postoperative complications
Time frame: 24 hours
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 17 Aug 2016.
- Derived from this study: PubMed 28437263Lee B, Soh S, Shim JK, Kim HY, Lee H, Kwak YL. Evaluation of preoperative oral carbohydrate administration on insulin resistance in off-pump coronary artery bypass patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):740-747. doi: 10.1097/EJA.0000000000000637.
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 carbohydrate beverage in people with Coronary Artery Occlusive Dissease, run by Yonsei University at 1 site in South Korea.
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 1 inclusion and 8 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 17 Aug 2016. 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 South Korea. 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 (time frame: within 1 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02330263, which also lists 1 linked publication.
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 17 Aug 2016.