Gastric Volume After Ingestion of Carbohydrate Drink vs Water in Obese Volunteers

NCT ID: NCT05827029

Last Updated: 2023-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Gastric Emptying

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Preoperative carbohydrate drink

Group Type EXPERIMENTAL

Preopertive drink

Intervention Type PROCEDURE

* 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.

Water

Group Type PLACEBO_COMPARATOR

Preopertive drink

Intervention Type PROCEDURE

* 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Age 18 - 65 years old
* BMI ≥ 30 kg/m2
* NPO for at least 6 hours before the study

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Chanatthee Kitsiripant

Asst.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chanatthee Kitsiripant

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University

Locations

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Department of Anesthesiology, Faculty pf Medicine

Songkhla, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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REC.65-236-8-1

Identifier Type: -

Identifier Source: org_study_id

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