Gestational Diabetes MellitusNCT05508425
Comparing the Effects of Water Temperature and Actives in Glucose Solution on Pregnant Women
A study testing oral glucose tolerance test using water at room temperature, oral glucose tolerance test using hot water and oral glucose tolerance test using cold water in people with Gestational Diabetes Mellitus, run by Chiayi Christian Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- oral glucose tolerance test using water at room temperature, oral glucose tolerance test using hot water and oral glucose tolerance test using cold water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2021to 5 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women
- Gestational age between 24 and 28 weeks
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City
About this study
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
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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- 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
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose tolerance test using water at room temperatureDiagnostic test
The use of water at room temperature to solve the 75g glucose.
oral glucose tolerance test using hot waterDiagnostic test
The use of hot water to solve the 75g glucose.
oral glucose tolerance test using cold waterDiagnostic test
The use of cold water to solve the 75g glucose.
oral glucose tolerance test using hot water with tea bagDiagnostic test
The use of hot water with tea bag to solve the 75g glucose.
oral glucose tolerance test using room temperature water with tea bagDiagnostic test
The use of room temperature water with tea bag to solve the 75g glucose.
oral glucose tolerance test using cold water with tea bagDiagnostic test
The use of cold water with tea bag to solve the 75g glucose.
Oral glucose tolerance test using bubble water at room temperatureDiagnostic test
The use of bubble water at room temperature to solve the 75g glucose.
Oral glucose tolerance test using bubble waterDiagnostic test
The use of cold bubble water to solve the 75g glucose.
| Study group | Role | What they receive |
|---|---|---|
| water at room temperature | Active comparator | Not described Receives: Diagnostic Test: oral glucose tolerance test using water at room temperature |
| hot water | Experimental | Not described Receives: Diagnostic Test: oral glucose tolerance test using hot water |
| cold water | Experimental | Not described Receives: Diagnostic Test: oral glucose tolerance test using cold water |
| hot water with tea bag | Experimental | Not described Receives: Diagnostic Test: oral glucose tolerance test using hot water with tea bag |
| room temperature water with tea bag | Experimental | Not described Receives: Diagnostic Test: oral glucose tolerance test using room temperature water with tea bag |
| cold water with tea bag | Experimental | Not described Receives: Diagnostic Test: oral glucose tolerance test using cold water with tea bag |
| bubble water at room temperature | Experimental | Not described Receives: Diagnostic Test: Oral glucose tolerance test using bubble water at room temperature |
| cold bubble water | Experimental | Not described Receives: Diagnostic Test: Oral glucose tolerance test using bubble water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycaemia level
Glycaemia level just before glucose administration
Measured: Glycaemia level was measured just before glucose administration.
Glycaemia level
Glycaemia level at 1 hour after glucose administration
Measured: Glycaemia level was measured at 1 hour after glucose administration
Glycaemia level
Glycaemia level at 2 hour after glucose administration
Measured: Glycaemia level was measured at 2 hours after glucose administration
gestational diabetes mellitus
gestational diabetes mellitus just before glucose administration.
Measured: Just before glucose administration.
gestational diabetes mellitus
gestational diabetes mellitus at 1 hour after glucose administration.
Measured: At 1 hour after glucose administration
gestational diabetes mellitus
gestational diabetes mellitus at 2 hour after glucose administration.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Just after glucose solution administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Nov 2021
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508425
- Sponsor's protocol ID
- IRB2021110
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang P, Chang PC, Wang CY, Wang LC, Shih CL. Comparing the effects of water temperature and additives in glucose solution on pregnant women's taste, side effects, and glycemic levels during an oral glucose tolerance test: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Apr;5(4):100870. doi: 10.1016/j.ajogmf.2023.100870. Epub 2023 Jan 20.
PubMed 36690181
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05508425
- Acronym / sponsor ID
- IRB2021110
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| water at room temperature | Active comparator | Diagnostic Test: oral glucose tolerance test using water at room temperature |
| hot water | Experimental | Diagnostic Test: oral glucose tolerance test using hot water |
| cold water | Experimental | Diagnostic Test: oral glucose tolerance test using cold water |
| hot water with tea bag | Experimental | Diagnostic Test: oral glucose tolerance test using hot water with tea bag |
| room temperature water with tea bag | Experimental | Diagnostic Test: oral glucose tolerance test using room temperature water with tea bag |
| cold water with tea bag | Experimental | Diagnostic Test: oral glucose tolerance test using cold water with tea bag |
| bubble water at room temperature | Experimental | Diagnostic Test: Oral glucose tolerance test using bubble water at room temperature |
| cold bubble water | Experimental | Diagnostic Test: Oral glucose tolerance test using bubble water |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women
- Gestational age between 24 and 28 weeks
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral glucose tolerance test using water at room temperatureThe use of water at room temperature to solve the 75g glucose. | Diagnostic test | water at room temperature |
| oral glucose tolerance test using hot waterThe use of hot water to solve the 75g glucose. | Diagnostic test | hot water |
| oral glucose tolerance test using cold waterThe use of cold water to solve the 75g glucose. | Diagnostic test | cold water |
| oral glucose tolerance test using hot water with tea bagThe use of hot water with tea bag to solve the 75g glucose. | Diagnostic test | hot water with tea bag |
| oral glucose tolerance test using room temperature water with tea bagThe use of room temperature water with tea bag to solve the 75g glucose. | Diagnostic test | room temperature water with tea bag |
| oral glucose tolerance test using cold water with tea bagThe use of cold water with tea bag to solve the 75g glucose. | Diagnostic test | cold water with tea bag |
| Oral glucose tolerance test using bubble water at room temperatureThe use of bubble water at room temperature to solve the 75g glucose. | Diagnostic test | bubble water at room temperature |
| Oral glucose tolerance test using bubble waterThe use of cold bubble water to solve the 75g glucose. | Diagnostic test | cold bubble water |
Primary outcome
Glycaemia level
Time frame: Glycaemia level was measured just before glucose administration.
Glycaemia level just before glucose administration
Glycaemia level
Time frame: Glycaemia level was measured at 1 hour after glucose administration
Glycaemia level at 1 hour after glucose administration
Glycaemia level
Time frame: Glycaemia level was measured at 2 hours after glucose administration
Glycaemia level at 2 hour after glucose administration
gestational diabetes mellitus
Time frame: Just before glucose administration.
gestational diabetes mellitus just before glucose administration.
gestational diabetes mellitus
Time frame: At 1 hour after glucose administration
gestational diabetes mellitus at 1 hour after glucose administration.
gestational diabetes mellitus
Time frame: At 2 hour after glucose administration
gestational diabetes mellitus at 2 hour after glucose administration.
Satisfaction after glucose solution administration
Time frame: 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).
Taste after glucose solution administration
Time frame: 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).
Nausea after glucose solution administration
Time frame: 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)
Vomiting after glucose solution administration
Time frame: 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)
Headache after glucose solution administration
Time frame: 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)
Abdominal bloating after glucose solution administration
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Derived from this study: PubMed 36690181Wang P, Chang PC, Wang CY, Wang LC, Shih CL. Comparing the effects of water temperature and additives in glucose solution on pregnant women's taste, side effects, and glycemic levels during an oral glucose tolerance test: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Apr;5(4):100870. doi: 10.1016/j.ajogmf.2023.100870. Epub 2023 Jan 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral glucose tolerance test using water at room temperature, oral glucose tolerance test using hot water and oral glucose tolerance test using cold water in people with Gestational Diabetes Mellitus, run by Chiayi Christian Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycaemia level (time frame: Glycaemia level was measured just before glucose administration.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.