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

Study Overview
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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.

Official Title
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Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obese Volunteers: A Randomized Crossover Study

Conditions
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Obesity, Gastric Emptying

Intervention / Treatment
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* Procedure: Preopertive drink


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative carbohydrate drink<br> | Procedure: Preopertive drink<br>* 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.<br>|
| Placebo Comparator: Water<br> | Procedure: Preopertive drink<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric residual volume | changes in gastric residual volume during 2 hours after drinking | baseline and every 30 minutes until 2 hours after drinking | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to empty gastric antrum |  | baseline and 120 minutes after drinking | 
| POCT glucose | changes in glucose level after ingest carbohydrate drink or water | baseline and 120 minutes after drinking | 
| thirst and hunger level | thirst and hunger level will be evaluated by visual rating scale | baseline and 120 minutes after drinking | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric residual volume, obesity, carbohydrate drink