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

Gestational Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508425
• Other study ID #: IRB2021110
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 5, 2022

Study information

• Verified date: August 2022
• Source: Chiayi Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: July 5, 2022
• Est. primary completion date: July 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Diagnostic Test:
• oral glucose tolerance test using water at room temperature
The use of water at room temperature to solve the 75g glucose.
• oral glucose tolerance test using hot water
The use of hot water to solve the 75g glucose.
• oral glucose tolerance test using cold water
The use of cold water to solve the 75g glucose.
• oral glucose tolerance test using hot water with tea bag
The use of hot water with tea bag to solve the 75g glucose.
• 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.
• oral glucose tolerance test using cold water with tea bag
The use of cold water with tea bag to solve the 75g glucose.
• Oral glucose tolerance test using bubble water at room temperature
The use of bubble water at room temperature to solve the 75g glucose.
• Oral glucose tolerance test using bubble water
The use of cold bubble water to solve the 75g glucose.

Locations

Country	Name	City	State
Taiwan	Ditmanson Medical Foundation Chia-Yi Christian Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chiayi Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemia level	Glycaemia level just before glucose administration	Glycaemia level was measured just before glucose administration.
Primary	Glycaemia level	Glycaemia level at 1 hour after glucose administration	Glycaemia level was measured at 1 hour after glucose administration
Primary	Glycaemia level	Glycaemia level at 2 hour after glucose administration	Glycaemia level was measured at 2 hours after glucose administration
Primary	gestational diabetes mellitus	gestational diabetes mellitus just before glucose administration.	Just before glucose administration.
Primary	gestational diabetes mellitus	gestational diabetes mellitus at 1 hour after glucose administration.	At 1 hour after glucose administration
Primary	gestational diabetes mellitus	gestational diabetes mellitus at 2 hour after glucose administration.	At 2 hour after glucose administration
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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