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

Primary Purpose

Gestational Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
oral glucose tolerance test using water at room temperature
oral glucose tolerance test using hot water
oral glucose tolerance test using cold water
oral glucose tolerance test using hot water with tea bag
oral glucose tolerance test using room temperature water with tea bag
oral glucose tolerance test using cold water with tea bag
Oral glucose tolerance test using bubble water at room temperature
Oral glucose tolerance test using bubble water
Sponsored by
Chiayi Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gestational Diabetes Mellitus

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

water at room temperature

hot water

cold water

hot water with tea bag

room temperature water with tea bag

cold water with tea bag

bubble water at room temperature

cold bubble water

Arm Description

Outcomes

Primary Outcome Measures

Glycaemia level
Glycaemia level just before glucose administration
Glycaemia level
Glycaemia level at 1 hour after glucose administration
Glycaemia level
Glycaemia level at 2 hour after glucose administration
gestational diabetes mellitus
gestational diabetes mellitus just before glucose administration.
gestational diabetes mellitus
gestational diabetes mellitus at 1 hour after glucose administration.
gestational diabetes mellitus
gestational diabetes mellitus 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).
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).
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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
August 10, 2022
Last Updated
August 17, 2022
Sponsor
Chiayi Christian Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05508425
Brief Title
Comparing the Effects of Water Temperature and Actives in Glucose Solution on Pregnant Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
July 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiayi Christian Hospital

4. Oversight

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

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
water at room temperature
Arm Type
Active Comparator
Arm Title
hot water
Arm Type
Experimental
Arm Title
cold water
Arm Type
Experimental
Arm Title
hot water with tea bag
Arm Type
Experimental
Arm Title
room temperature water with tea bag
Arm Type
Experimental
Arm Title
cold water with tea bag
Arm Type
Experimental
Arm Title
bubble water at room temperature
Arm Type
Experimental
Arm Title
cold bubble water
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
oral glucose tolerance test using water at room temperature
Intervention Description
The use of water at room temperature to solve the 75g glucose.
Intervention Type
Diagnostic Test
Intervention Name(s)
oral glucose tolerance test using hot water
Intervention Description
The use of hot water to solve the 75g glucose.
Intervention Type
Diagnostic Test
Intervention Name(s)
oral glucose tolerance test using cold water
Intervention Description
The use of cold water to solve the 75g glucose.
Intervention Type
Diagnostic Test
Intervention Name(s)
oral glucose tolerance test using hot water with tea bag
Intervention Description
The use of hot water with tea bag to solve the 75g glucose.
Intervention Type
Diagnostic Test
Intervention Name(s)
oral glucose tolerance test using room temperature water with tea bag
Intervention Description
The use of room temperature water with tea bag to solve the 75g glucose.
Intervention Type
Diagnostic Test
Intervention Name(s)
oral glucose tolerance test using cold water with tea bag
Intervention Description
The use of cold water with tea bag to solve the 75g glucose.
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral glucose tolerance test using bubble water at room temperature
Intervention Description
The use of bubble water at room temperature to solve the 75g glucose.
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral glucose tolerance test using bubble water
Intervention Description
The use of cold bubble water to solve the 75g glucose.
Primary Outcome Measure Information:
Title
Glycaemia level
Description
Glycaemia level just before glucose administration
Time Frame
Glycaemia level was measured just before glucose administration.
Title
Glycaemia level
Description
Glycaemia level at 1 hour after glucose administration
Time Frame
Glycaemia level was measured at 1 hour after glucose administration
Title
Glycaemia level
Description
Glycaemia level at 2 hour after glucose administration
Time Frame
Glycaemia level was measured at 2 hours after glucose administration
Title
gestational diabetes mellitus
Description
gestational diabetes mellitus just before glucose administration.
Time Frame
Just before glucose administration.
Title
gestational diabetes mellitus
Description
gestational diabetes mellitus at 1 hour after glucose administration.
Time Frame
At 1 hour after glucose administration
Title
gestational diabetes mellitus
Description
gestational diabetes mellitus at 2 hour after glucose administration.
Time Frame
At 2 hour after glucose administration
Title
Satisfaction after glucose solution administration
Description
Satisfaction was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).
Time Frame
Just after glucose administration
Title
Taste after glucose solution administration
Description
Taste was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).
Time Frame
Just after glucose administration
Title
Nausea after glucose solution administration
Description
Nausea was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)
Time Frame
Just after glucose administration
Title
Vomiting after glucose solution administration
Description
Vomiting was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)
Time Frame
Just after glucose solution administration
Title
Headache after glucose solution administration
Description
Headache was measured by a questionnaire using 5-point Likert scale (1: not at all; 2: slightly; 3: neutral; 4: serious; 5: very serious)
Time Frame
Just after glucose solution administration
Title
Abdominal bloating after glucose solution administration
Description
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)
Time Frame
Just after glucose solution administration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ditmanson Medical Foundation Chia-Yi Christian Hospital
City
Chiayi City
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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