Carbohydrate IntoleranceNoNPONCT04456166
Safety of Preoperative Carbohydrate Loading in Diabetic Patients
An observational study of Carbohydrate Intolerance and Diabetes Mellitus Type 2, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the safety of preoperative carbohydrate loading in diabetic patients undergoing general anesthesia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbohydrate Intolerance, Diabetes Mellitus Type 2
- What is being tested?
- noNPO
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jun 2020to 4 May 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients over 18 years of age who are scheduled to undergo general anesthesia are subject to preoperative carbohydrodritate loading and diagnosed with type 2 diabetes taking oral hypoglycemic agents
Who may be able to join
- Elective surgery
- Type 2 diabetes mellitus on oral hypoglycemic agents
- American Society of Anesthesiologists physical status 2 or 3
- Ages 18 or more
- Approve to participate
Who cannot join
- Ambulatory surgery
- BMI >35
- History of gastric or esophagus surgery
- History of GERD, dyspepesia or
- Anticipated difficult intubation (previous III or more Cormack and Lehane's grade, Mallamgrade, Mallampati scpati scoreore III or moreIII or more, propro/retro/retrognathism, gnathism, thyromental distance<6.5cm, thyromental distance<6.5cm, limited mouth openinglimited mouth opening)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongnogu, 03080
About this study
Official title: Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia
The purpose of this study is to investigate the safety of preoperative carbohydrate loading in diabetic patients undergoing general anesthesia
- Conditions
- Carbohydrate Intolerance, Diabetes Mellitus Type 2
- Being tested
- noNPO
- Keywords
- Carbohydrate Intolerance, Diabetes Mellitus, Diabetes Mellitus, Type 2, Carbohydrate loading
- Medical subject headings
- Glucose-Galactose Malabsorption, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noNPODietary supplement
Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting will be asked to be enrolled into the study.
Before induction of general anesthesia, all patients were evaluated the gastric volume under ultrasonography.
| Study group | Role | What they receive |
|---|---|---|
| Patient who received carbohydrate loading | Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting Receives: Dietary Supplement: noNPO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gastric ultrasonography score as low risk (grade 0 or 1)
Ultrasound assessment of gastric volume by gastroscopic examination.
Measured: 30 minutes after intubation
Secondary outcomes (6)
Gastric volume
Measured: 30 minutes after intubation
Blood sugar test
Measured: 30 minutes after intubation and 30 minutes after extubation
The incidence of insulin bolus injection
Measured: during operation
The incidence of insulin bolus injection
Measured: up to 30 minutes after extubation
Satisfaction scale of patients
Measured: up to 30 minutes after extubation
The incidence of nausea and vomiting
Measured: up to 30 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start22 Jun 2020
- Primary completion4 May 2021
- Study completion4 May 2021
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 Carbohydrate IntoleranceStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susie Yoon, Seoul National University Hospital
- Investigators
- Susie Yoon, MD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456166
- Sponsor's protocol ID
- 20030471108
- Acronym
- NoNPO
- Status last verified
- Oct 2021
- First submitted
- 25 Jun 2020
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee S, Sohn JY, Lee HJ, Yoon S, Bahk JH, Kim BR. Effect of pre-operative carbohydrate loading on aspiration risk evaluated with ultrasonography in type 2 diabetes patients: a prospective observational pilot study. Sci Rep. 2022 Oct 20;12(1):17521. doi: 10.1038/s41598-022-21696-1.
PubMed 36266449
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT04456166
- Acronym / sponsor ID
- NoNPO / 20030471108
- Conditions
- Carbohydrate Intolerance, Diabetes Mellitus Type 2
- Keywords
- Carbohydrate Intolerance, Diabetes Mellitus, Diabetes Mellitus, Type 2, Carbohydrate loading
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 2 Jul 2020 (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.
The purpose of this study is to investigate the safety of preoperative carbohydrate loading in diabetic patients undergoing general anesthesia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient who received carbohydrate loading | – | Dietary Supplement: noNPOPatients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age who are scheduled to undergo general anesthesia are subject to preoperative carbohydrodritate loading and diagnosed with type 2 diabetes taking oral hypoglycemic agents
Key inclusion criteria (5 listed)
- Elective surgery
- Type 2 diabetes mellitus on oral hypoglycemic agents
- American Society of Anesthesiologists physical status 2 or 3
- Ages 18 or more
- Approve to participate
Key exclusion criteria (5 listed)
- Ambulatory surgery
- BMI >35
- History of gastric or esophagus surgery
- History of GERD, dyspepesia or
- Anticipated difficult intubation (previous III or more Cormack and Lehane's grade, Mallamgrade, Mallampati scpati scoreore III or moreIII or more, propro/retro/retrognathism, gnathism, thyromental distance<6.5cm, thyromental distance<6.5cm, limited mouth openinglimited mouth opening)
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 |
|---|---|---|
| noNPOPatients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting will be asked to be enrolled into the study. Before induction of general anesthesia, all patients were evaluated the gastric volume under ultrasonography. | Dietary supplement | Patient who received carbohydrate loading |
Primary outcome
Incidence of gastric ultrasonography score as low risk (grade 0 or 1)
Time frame: 30 minutes after intubation
Ultrasound assessment of gastric volume by gastroscopic examination.
6 secondary outcomes
Gastric volume
Time frame: 30 minutes after intubation
Blood sugar test
Time frame: 30 minutes after intubation and 30 minutes after extubation
The incidence of insulin bolus injection
Time frame: during operation
The incidence of insulin bolus injection
Time frame: up to 30 minutes after extubation
Satisfaction scale of patients
Time frame: up to 30 minutes after extubation
The incidence of nausea and vomiting
Time frame: up to 30 minutes after extubation
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 15 Oct 2021.
- Derived from this study: PubMed 36266449Lee S, Sohn JY, Lee HJ, Yoon S, Bahk JH, Kim BR. Effect of pre-operative carbohydrate loading on aspiration risk evaluated with ultrasonography in type 2 diabetes patients: a prospective observational pilot study. Sci Rep. 2022 Oct 20;12(1):17521. doi: 10.1038/s41598-022-21696-1.
- Individual participant dataSharing planned: Undecided
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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.
Susie Yoon, MD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbohydrate Intolerance and Diabetes Mellitus Type 2, run by Seoul National University Hospital 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 5 inclusion and 5 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 15 Oct 2021. 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?
Incidence of gastric ultrasonography score as low risk (grade 0 or 1) (time frame: 30 minutes after intubation). 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 NCT04456166, 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 15 Oct 2021.