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

Primary Purpose

Obesity, Gastric Emptying

Status
Active
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Preopertive drink
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Obesity focused on measuring gastric residual volume, obesity, carbohydrate drink

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Anesthesiology, Faculty pf Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Preoperative carbohydrate drink

Water

Arm Description

Outcomes

Primary Outcome Measures

gastric residual volume
changes in gastric residual volume during 2 hours after drinking

Secondary Outcome Measures

time to empty gastric antrum
POCT glucose
changes in glucose level after ingest carbohydrate drink or water
thirst and hunger level
thirst and hunger level will be evaluated by visual rating scale

Full Information

First Posted
April 9, 2023
Last Updated
April 21, 2023
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT05827029
Brief Title
Gastric Volume After Ingestion of Carbohydrate Drink vs Water in Obese Volunteers
Official Title
Comparison of Gastric Residual Volume After Ingestion of Carbohydrate Drink and Water in Obese Volunteers: A Randomized Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Gastric Emptying
Keywords
gastric residual volume, obesity, carbohydrate drink

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative carbohydrate drink
Arm Type
Experimental
Arm Title
Water
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Preopertive drink
Intervention Description
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.
Primary Outcome Measure Information:
Title
gastric residual volume
Description
changes in gastric residual volume during 2 hours after drinking
Time Frame
baseline and every 30 minutes until 2 hours after drinking
Secondary Outcome Measure Information:
Title
time to empty gastric antrum
Time Frame
baseline and 120 minutes after drinking
Title
POCT glucose
Description
changes in glucose level after ingest carbohydrate drink or water
Time Frame
baseline and 120 minutes after drinking
Title
thirst and hunger level
Description
thirst and hunger level will be evaluated by visual rating scale
Time Frame
baseline and 120 minutes after drinking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanatthee Kitsiripant
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, Faculty pf Medicine
City
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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

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