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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05827029
• Other study ID #: REC.65-236-8-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2023
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 patients? Participants also will be evaluated the level of thirst/hungry and blood sugar.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Emptying
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty pf Medicine	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastric residual volume	changes in gastric residual volume during 2 hours after drinking	baseline and every 30 minutes until 2 hours after drinking
Secondary	time to empty gastric antrum		baseline and 120 minutes after drinking
Secondary	POCT glucose	changes in glucose level after ingest carbohydrate drink or water	baseline and 120 minutes after drinking
Secondary	thirst and hunger level	thirst and hunger level will be evaluated by visual rating scale	baseline and 120 minutes after drinking