ObesityNCT05827029
Gastric Volume After Ingestion of Carbohydrate Drink vs Water in Obese Volunteers
A study testing Preopertive drink in people with Obesity and Gastric Emptying, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
This randomized crossover study compares gastric residual volume after ingestion of carbohydrate drinks and water in obese volunteers. The main question[s] it aims to answer are: Is it safe for obese patients to shorten their fasting by allowing preoperative drinks? How long is the gastric emptying time in obese… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Gastric Emptying
- What is being tested?
- Preopertive drink
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2023to 31 May 2023
- 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
- Healthy volunteers
- Age 18 - 65 years old
- BMI ≥ 30 kg/m2
- NPO for at least 6 hours before the study
Who cannot join
- Diabetes Mellitus
- Chronic kidney disease or End-stage renal disease
- Use of any medication that affects gastric secretion or emptying (Histamine 2 receptor antagonist eg. Ranitidine/Proton pump inhibitor eg. Omeprazole/Acid neutralization eg. Aluminium hydroxide/Prokinetic eg. Domperidone) within the past 24 hours
- Gastroesophageal reflux disease
- Pregnancy
- History of upper gastrointestinal surgery
- In diet program or use appetite suppressant drug (eg. Liraglutide, Naltrexone, Phentermine, Diethylpropion) within the past 24 hours
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Anesthesiology, Faculty pf Medicine
Songkhla, 90110
About this study
Official title: Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obese Volunteers: A Randomized Crossover Study
This randomized crossover study compares gastric residual volume after ingestion of carbohydrate drinks and water in obese volunteers. The main question[s] it aims to answer are:
- Is it safe for obese patients to shorten their fasting by allowing preoperative drinks?
- How long is the gastric emptying time in obese patients? Participants also will be evaluated the level of thirst/hungry and blood sugar.
- Conditions
- Obesity, Gastric Emptying
- Being tested
- Preopertive drink
- Keywords
- gastric residual volume, obesity, carbohydrate drink
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preopertive drinkProcedure or surgery
- Group C: will receive a carbohydrate drink of 400 ml (50 g of glucose prepared by nutrition division, same appearance and containing bottles of water)
- Group W: will receive water 400 ml (prepared by nutrition division, Songklanagarind hospital, same appearance and containing bottles of carbohydrate drink) In both groups, the received 400-mL drink was consumed within 5 minutes.
- Before drinking, baseline data (gastric residual volume, POCT glucose, degree of hunger, and thirst) will be evaluated.
- Gastric ultrasound will be performed by the same Radiologist on each participant at 0, 30, 60, 90, 120 minutes
- after drinking to evaluate the gastric residual volume and time to empty gastric antrum.
- POCT glucose and degree of hunger and thirst are also assessed again at 120 minutes after drinking.
- After completing one type of drinking, participants will be appointed again after 1 week later for doing the same protocol with another drinking.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative carbohydrate drink | Experimental | Not described Receives: Procedure: Preopertive drink |
| Water | Placebo comparator | Not described Receives: Procedure: Preopertive drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric residual volume
changes in gastric residual volume during 2 hours after drinking
Measured: baseline and every 30 minutes until 2 hours after drinking
Secondary outcomes (3)
time to empty gastric antrum
Measured: baseline and 120 minutes after drinking
POCT glucose
changes in glucose level after ingest carbohydrate drink or water
Measured: baseline and 120 minutes after drinking
thirst and hunger level
thirst and hunger level will be evaluated by visual rating scale
Measured: baseline and 120 minutes after drinking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Apr 2023
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chanatthee Kitsiripant, Prince of Songkla University
- Investigators
- Chanatthee Kitsiripant, Principal investigator, Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827029
- Sponsor's protocol ID
- REC.65-236-8-1
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 24 Apr 2023
- 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 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obese Volunteers: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT05827029
- Acronym / sponsor ID
- REC.65-236-8-1
- Conditions
- Obesity, Gastric Emptying
- Keywords
- gastric residual volume, obesity, carbohydrate drink
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 24 Apr 2023 (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.
This randomized crossover study compares gastric residual volume after ingestion of carbohydrate drinks and water in obese volunteers. The main question[s] it aims to answer are:
- Is it safe for obese patients to shorten their fasting by allowing preoperative drinks?
- How long is the gastric emptying time in obese patients? Participants also will be evaluated the level of thirst/hungry and blood sugar.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative carbohydrate drink | Experimental | Procedure: Preopertive drink |
| Water | Placebo comparator | Procedure: Preopertive drink |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Age 18 - 65 years old
- BMI ≥ 30 kg/m2
- NPO for at least 6 hours before the study
Key exclusion criteria (7 listed)
- Diabetes Mellitus
- Chronic kidney disease or End-stage renal disease
- Use of any medication that affects gastric secretion or emptying (Histamine 2 receptor antagonist eg. Ranitidine/Proton pump inhibitor eg. Omeprazole/Acid neutralization eg. Aluminium hydroxide/Prokinetic eg. Domperidone) within the past 24 hours
- Gastroesophageal reflux disease
- Pregnancy
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 |
|---|---|---|
| Preopertive drink* Group C: will receive a carbohydrate drink of 400 ml (50 g of glucose prepared by nutrition division, same appearance and containing bottles of water) * Group W: will receive water 400 ml (prepared by nutrition division, Songklanagarind hospital, same appearance and containing bottles of carbohydrate drink) In both groups, the received 400-mL drink was consumed within 5 minutes. * Before drinking, baseline data (gastric residual volume, POCT glucose, degree of hunger, and thirst) will be evaluated. * Gastric ultrasound will be performed by the same Radiologist on each participant at 0, 30, 60, 90, 120 minutes * after drinking to evaluate the gastric residual volume and time to empty gastric antrum. * POCT glucose and degree of hunger and thirst are also assessed again at 120 minutes after drinking. * After completing one type of drinking, participants will be appointed again after 1 week later for doing the same protocol with another drinking. | Procedure or surgery | Preoperative carbohydrate drink, Water |
Primary outcome
gastric residual volume
Time frame: baseline and every 30 minutes until 2 hours after drinking
changes in gastric residual volume during 2 hours after drinking
3 secondary outcomes
time to empty gastric antrum
Time frame: baseline and 120 minutes after drinking
POCT glucose
Time frame: baseline and 120 minutes after drinking
thirst and hunger level
Time frame: baseline and 120 minutes after drinking
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
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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.
Chanatthee Kitsiripant principal investigator
Department of Anesthesiology, Faculty of Medicine, 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 Preopertive drink in people with Obesity and Gastric Emptying, 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 7 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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?
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?
gastric residual volume (time frame: baseline and every 30 minutes until 2 hours after drinking). 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 2023.