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

Sponsor
Chiayi Christian Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05508425
Collaborator
(none)
400
Enrollment
1
Location
8
Arms
8.1
Actual Duration (Months)
49.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Nov 1, 2021
Actual Primary Completion Date :
Jul 5, 2022
Actual Study Completion Date :
Jul 5, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Glycaemia level [Glycaemia level was measured just before glucose administration.]

    Glycaemia level just before glucose administration

  2. Glycaemia level [Glycaemia level was measured at 1 hour after glucose administration]

    Glycaemia level at 1 hour after glucose administration

  3. Glycaemia level [Glycaemia level was measured at 2 hours after glucose administration]

    Glycaemia level at 2 hour after glucose administration

  4. gestational diabetes mellitus [Just before glucose administration.]

    gestational diabetes mellitus just before glucose administration.

  5. gestational diabetes mellitus [At 1 hour after glucose administration]

    gestational diabetes mellitus at 1 hour after glucose administration.

  6. gestational diabetes mellitus [At 2 hour after glucose administration]

    gestational diabetes mellitus at 2 hour after glucose administration.

  7. Satisfaction after glucose solution administration [Just after glucose administration]

    Satisfaction was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).

  8. Taste after glucose solution administration [Just after glucose administration]

    Taste was measured by a questionnaire using 5-point Likert scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied).

  9. Nausea after glucose solution administration [Just after glucose 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)

  10. Vomiting after glucose solution administration [Just 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)

  11. Headache after glucose solution administration [Just 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)

  12. Abdominal bloating after glucose solution administration [Just 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ditmanson Medical Foundation Chia-Yi Christian Hospital Chiayi City Taiwan

Sponsors and Collaborators

  • Chiayi Christian Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chiayi Christian Hospital
ClinicalTrials.gov Identifier:
NCT05508425
Other Study ID Numbers:
  • IRB2021110
First Posted:
Aug 19, 2022
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes, Gestational

Study Results

No Results Posted as of Aug 19, 2022