Comparing the Effects of Water Temperature and Actives in Glucose Solution on Pregnant Women

Comparing the Effects of Water Temperature and Actives in Glucose Solution on Pregnant Women's Taste and Side Effects During an Oral Glucose Tolerance Test-A Randomized Controlled Trial

To assess the effect of water temperature and additives on pregnant women's taste and side effect during the oral glucose tolerance test (OGTT) evaluation.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Diagnostic test: oral glucose tolerance test using water at room temperature; Diagnostic test: oral glucose tolerance test using hot water; Diagnostic test: oral glucose tolerance test using cold water; Diagnostic test: oral glucose tolerance test using hot water with tea bag; Diagnostic test: oral glucose tolerance test using room temperature water with tea bag; Diagnostic test: oral glucose tolerance test using cold water with tea bag; Diagnostic test: Oral glucose tolerance test using bubble water at room temperature; Diagnostic test: Oral glucose tolerance test using bubble water

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi City, Taiwan
    • Ditmanson Medical Foundation Chia-Yi Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women
• Gestational age between 24 and 28 weeks

Exclusion Criteria:

• Clinical diagnosis of overt type 2 diabetes
• Clinical diagnosis of facial palsy
• Clinical diagnosis of oral cavity and throat
• Clinical diagnosis of hypothyroidism
• Clinical diagnosis of chronic hepatitis
• Clinical diagnosis of kidney disease .Clinical diagnosis of Sicca syndrome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: water at room temperature	Diagnostic test: oral glucose tolerance test using water at room temperature; The use of water at room temperature to solve the 75g glucose.
EXPERIMENTAL: hot water	Diagnostic test: oral glucose tolerance test using hot water; The use of hot water to solve the 75g glucose.
EXPERIMENTAL: cold water	Diagnostic test: oral glucose tolerance test using cold water; The use of cold water to solve the 75g glucose.
EXPERIMENTAL: hot water with tea bag	Diagnostic test: oral glucose tolerance test using hot water with tea bag; The use of hot water with tea bag to solve the 75g glucose.
EXPERIMENTAL: room temperature water with tea bag	Diagnostic test: oral glucose tolerance test using room temperature water with tea bag; The use of room temperature water with tea bag to solve the 75g glucose.
EXPERIMENTAL: cold water with tea bag	Diagnostic test: oral glucose tolerance test using cold water with tea bag; The use of cold water with tea bag to solve the 75g glucose.
EXPERIMENTAL: bubble water at room temperature	Diagnostic test: Oral glucose tolerance test using bubble water at room temperature; The use of bubble water at room temperature to solve the 75g glucose.
EXPERIMENTAL: cold bubble water	Diagnostic test: Oral glucose tolerance test using bubble water; The use of cold bubble water to solve the 75g glucose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycaemia level	Glycaemia level just before glucose administration	Glycaemia level was measured just before glucose administration.
Glycaemia level	Glycaemia level at 1 hour after glucose administration	Glycaemia level was measured at 1 hour after glucose administration
Glycaemia level	Glycaemia level at 2 hour after glucose administration	Glycaemia level was measured at 2 hours after glucose administration
gestational diabetes mellitus	gestational diabetes mellitus just before glucose administration.	Just before glucose administration.
gestational diabetes mellitus	gestational diabetes mellitus at 1 hour after glucose administration.	At 1 hour after glucose administration
gestational diabetes mellitus	gestational diabetes mellitus at 2 hour after glucose administration.	At 2 hour after glucose administration
Satisfaction after glucose solution administration	Satisfaction was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).	Just after glucose administration
Taste after glucose solution administration	Taste was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).	Just after glucose administration
Nausea after glucose solution administration	Nausea was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)	Just after glucose administration
Vomiting after glucose solution administration	Vomiting was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)	Just after glucose solution administration
Headache after glucose solution administration	Headache was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)	Just after glucose solution administration
Abdominal bloating after glucose solution administration	Abdominal bloating was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)	Just after glucose solution administration

Collaborators and Investigators

• Sponsor: Chiayi Christian Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2021
• Primary Completion (ACTUAL): July 5, 2022
• Study Completion (ACTUAL): July 5, 2022

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (ACTUAL): August 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: IRB2021110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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