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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Gastric Emptying
• Intervention / Treatment: Procedure: Preopertive drink

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Songkhla, Thailand, 90110
    • Department of Anesthesiology, Faculty pf Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Water	Procedure: 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.
Experimental: Preoperative carbohydrate drink	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Chanatthee Kitsiripant, Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: April 9, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: gastric residual volume, obesity, carbohydrate drink
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: REC.65-236-8-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No