ObesityCarbDrinkUltraNCT06941623
Ultrasound Assessment for Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obesity Class II and III Volunteers at Risk of Aspiration
A study testing Ultrasonography of gastric residual volume, Point-of-care testing of glucose and Hunger numeric rating scale in people with Obesity and Gastroesophageal Reflux, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to compare gastric residual volume between drinking a carbohydrate drink and water in obesity class II and III volunteers at risk of aspiration. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Gastroesophageal Reflux
- What is being tested?
- Ultrasonography of gastric residual volume, Point-of-care testing of glucose and Hunger numeric rating scale
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2023to 26 May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 35 kg/m2 (obesity class II and III)
- Gastroesophageal reflux disease and/or active gastroesophageal reflux symptoms in 6 months (heartburn and/or acid regurgitation)
- ASA status I-III
- NPO for 8 hours before the study
Who cannot join
- Chronic kidney disease or End-stage renal disease
- Diabetes Mellitus
- Use of any medication that affects gastric secretion or emptying within the past 24-hour
- Pregnancy
- History of major upper gastrointestinal surgery
- Allergy to ultrasound gel
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of medicine, Songklanagarind Hospital
Hat Yai, Changwat Songkhla, 90110
About this study
Official title: Ultrasound Assessment for Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obesity Class II and III Volunteers at Risk of Aspiration: A Randomized Crossover Study
The goal of this clinical trial is to compare gastric residual volume between drinking a carbohydrate drink and water in obesity class II and III volunteers at risk of aspiration.
- Conditions
- Obesity, Gastroesophageal Reflux
- Being tested
- Ultrasonography of gastric residual volume, Point-of-care testing of glucose, Hunger numeric rating scale, Thirst numeric rating scale, Nausea numeric rating scale
- Keywords
- Carbohydrate drink, Gastric residual volume, Gastric ultrasound
- Medical subject headings
- Obesity, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography of gastric residual volumeDiagnostic test
Also called GRV
Gastric ultrasound will be performed by the radiologist on each participant before the study and at 0, 10, 20, 30, 60, 90, 120 minutes after drinking in the position of head upright 45 degree with left lateral decubitus to evaluate the gastric residual volume and time to empty gastric antrum. If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes.
Point-of-care testing of glucoseDiagnostic test
Also called POCT glucose, DTX
We will perform the point-of-care test of glucose before the study and at 60, and 120 minutes after drinking.
Hunger numeric rating scaleOther
Also called Hunger NRS
Hunger will be measured by a numeric rating scale(NRS) before drinking, 60 and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of hunger levels, defined by numbers from 0 to 10, where 0 represents the lowest level of hunger and 10 represents the highest.
Thirst numeric rating scaleOther
Also called Thirst NRS
Thirst will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of thirst levels, defined by numbers from 0 to 10, where 0 represents the lowest level of thirst and 10 represents the highest.
Nausea numeric rating scaleOther
Also called Nausea NRS
Nausea will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of nausea levels, defined by numbers from 0 to 10, where 0 represents the lowest level of nausea and 10 represents the highest.
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate drink | Experimental | Volunteers receive a carbohydrate drink of 400 ml (50 g of glucose, clear color, same appearance, and containing bottles of water, prepared by the nutrition division, Songklanagarind hospital) Receives: Diagnostic Test: Ultrasonography of gastric residual volume; Diagnostic Test: Point-of-care testing of glucose; Other: Hunger numeric rating scale; Other: Thirst numeric rating scale; Other: Nausea numeric rating scale |
| Water | Placebo comparator | Volunteers receive a bottle of 400 ml water (clear color, same appearance, and containing bottles of carbohydrate drink, prepared by the nutrition division, Songklanagarind hospital) Receives: Diagnostic Test: Ultrasonography of gastric residual volume; Diagnostic Test: Point-of-care testing of glucose; Other: Hunger numeric rating scale; Other: Thirst numeric rating scale; Other: Nausea numeric rating scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Residual Volume
gastric ultrasound at the gastric antrum by ultrasound
Measured: before the study and 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm.If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes.
Secondary outcomes (5)
Time to empty gastric antrum
Duration after drinking the drink until the gastric antrum cross-sectional area < 1.5 ml/kg measure by ultrasound
Measured: 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm. If participants doesn't be empty stomach, time will extended to 120 and 180 minutes.
Point-of-care testing(POCT) glucose
measured by point-of-care testing(POCT) glucose at every 60 minutes entire the study
Measured: Point-of-care testing(POCT) glucose is measured before the study, 60 and 120 after drinking the prepared drink each arm.
Hunger Numeric Rating Scale(NRS)
Hunger will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of hunger levels, defined by numbers from 0 to 10, where 0 represents the lowest level of hunger and 10 represents the highest.
Measured: before the study, 60, and 120 minutes after drinking the prepared drink each arm
Thirst Numeric Rating Scale(NRS)
Thirst will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of thirst levels, defined by numbers from 0 to 10, where 0 represents the lowest level of thirst and 10 represents the highest.
Measured: before the study, 60, and 120 minutes after drinking the prepared drink each arm
Nausea Numeric Rating Scale(NRS)
Nausea will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of nausea levels, defined by numbers from 0 to 10, where 0 represents the lowest level of nausea and 10 represents the highest.
Measured: before the study, 60, and 120 minutes after drinking the prepared drink each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Feb 2023
- Primary completion19 May 2024
- Study completion26 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chanya Deekiatphaiboon, Prince of Songkla University
- Investigators
- Chanya Deekiatphaiboon, Principal investigator, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941623
- Sponsor's protocol ID
- REC 66-538-8-1
- Acronym
- CarbDrinkUltra
- Status last verified
- Apr 2025
- First submitted
- 8 Mar 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment for Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obesity Class II and III Volunteers at Risk of Aspiration: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT06941623
- Acronym / sponsor ID
- CarbDrinkUltra / REC 66-538-8-1
- Conditions
- Obesity, Gastroesophageal Reflux
- Keywords
- Carbohydrate drink, Gastric residual volume, Gastric ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 19 May 2024 (actual)
- Study completion
- 26 May 2024 (actual)
- First posted
- 24 Apr 2025 (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 goal of this clinical trial is to compare gastric residual volume between drinking a carbohydrate drink and water in obesity class II and III volunteers at risk of aspiration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate drink | Experimental | Diagnostic Test: Ultrasonography of gastric residual volume, Diagnostic Test: Point-of-care testing of glucose, Other: Hunger numeric rating scale, Other: Thirst numeric rating scale, Other: Nausea numeric rating scaleVolunteers receive a carbohydrate drink of 400 ml (50 g of glucose, clear color, same appearance, and containing bottles of water, prepared by the nutrition division, Songklanagarind hospital) |
| Water | Placebo comparator | Diagnostic Test: Ultrasonography of gastric residual volume, Diagnostic Test: Point-of-care testing of glucose, Other: Hunger numeric rating scale, Other: Thirst numeric rating scale, Other: Nausea numeric rating scaleVolunteers receive a bottle of 400 ml water (clear color, same appearance, and containing bottles of carbohydrate drink, prepared by the nutrition division, Songklanagarind hospital) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI ≥ 35 kg/m2 (obesity class II and III)
- Gastroesophageal reflux disease and/or active gastroesophageal reflux symptoms in 6 months (heartburn and/or acid regurgitation)
- ASA status I-III
- NPO for 8 hours before the study
Key exclusion criteria (6 listed)
- Chronic kidney disease or End-stage renal disease
- Diabetes Mellitus
- Use of any medication that affects gastric secretion or emptying within the past 24-hour
- Pregnancy
- History of major upper gastrointestinal surgery
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 |
|---|---|---|
| Ultrasonography of gastric residual volumeAlso: GRVGastric ultrasound will be performed by the radiologist on each participant before the study and at 0, 10, 20, 30, 60, 90, 120 minutes after drinking in the position of head upright 45 degree with left lateral decubitus to evaluate the gastric residual volume and time to empty gastric antrum. If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes. | Diagnostic test | Carbohydrate drink, Water |
| Point-of-care testing of glucoseAlso: POCT glucose, DTXWe will perform the point-of-care test of glucose before the study and at 60, and 120 minutes after drinking. | Diagnostic test | Carbohydrate drink, Water |
| Hunger numeric rating scaleAlso: Hunger NRSHunger will be measured by a numeric rating scale(NRS) before drinking, 60 and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of hunger levels, defined by numbers from 0 to 10, where 0 represents the lowest level of hunger and 10 represents the highest. | Other | Carbohydrate drink, Water |
| Thirst numeric rating scaleAlso: Thirst NRSThirst will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of thirst levels, defined by numbers from 0 to 10, where 0 represents the lowest level of thirst and 10 represents the highest. | Other | Carbohydrate drink, Water |
| Nausea numeric rating scaleAlso: Nausea NRSNausea will be measured by a numeric rating scale(NRS) before drinking, 60, and 120 minutes after drinking. The Numeric Rating Scale(NRS) is used for the self-report measurement of nausea levels, defined by numbers from 0 to 10, where 0 represents the lowest level of nausea and 10 represents the highest. | Other | Carbohydrate drink, Water |
Primary outcome
Gastric Residual Volume
Time frame: before the study and 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm.If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes.
gastric ultrasound at the gastric antrum by ultrasound
5 secondary outcomes
Time to empty gastric antrum
Time frame: 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm. If participants doesn't be empty stomach, time will extended to 120 and 180 minutes.
Point-of-care testing(POCT) glucose
Time frame: Point-of-care testing(POCT) glucose is measured before the study, 60 and 120 after drinking the prepared drink each arm.
Hunger Numeric Rating Scale(NRS)
Time frame: before the study, 60, and 120 minutes after drinking the prepared drink each arm
Thirst Numeric Rating Scale(NRS)
Time frame: before the study, 60, and 120 minutes after drinking the prepared drink each arm
Nausea Numeric Rating Scale(NRS)
Time frame: before the study, 60, and 120 minutes after drinking the prepared drink each arm
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 24 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Chanya Deekiatphaiboon principal investigator
Prince of Songkla University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography of gastric residual volume, Point-of-care testing of glucose and Hunger numeric rating scale in people with Obesity and Gastroesophageal Reflux, run by Prince of Songkla University at 1 site in Thailand.
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 4 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: finished, as of the sponsor's last update on 24 Apr 2025. 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 Thailand. 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 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?
Gastric Residual Volume (time frame: before the study and 0, 10, 20, 30, 60, 90, 120 minutes after drinking the prepared drink each arm.If time to empty gastric antrum is extended, ultrasound will be serial performed at 150 and 180 minutes.). 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 24 Apr 2025.