Gestational DiabetesNCT06753734
Early Prediction of Gestational Diabetes in High-risk Women Based on Breath Metabolomics
An observational study of Gestational Diabetes, run by Tianjin Central Hospital of Gynecology Obstetrics at 1 site in China.
Trial summary
This study aim to develope novel breath markers of gestational diabetes through a prospective high-risk population cohort study and achieve early prediction of gestational diabetes based on an interpretable machine learning model. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The population in this study include pregnant women aged 18-55 years and at 11-14 weeks gestation with at least one risk factor for GDM
Who may be able to join
None listed.
Who cannot join
- Diabetes mellitus or abnormal glucose metabolism before pregnancy
- Hyperemesis gravidarum (urine ketone positive))
- Thyroid dysfunction
- Asthmatic patients
- Hypertensive diseases that are difficult to control
- Severe hepatic and renal insufficiency or severe electrolyte disturbance
Show all 12Show fewer
- Malignant tumor
- Acute inflammation
- lung disease
- Patients with gastritis, duodenum and other digestive system diseases
- Those with upper respiratory or oral problems who cannot cooperate with expiratory collection
- smoker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Cohort Study in Women at High Risk for Gestational Diabetes Based on Breath Metabolomics
This study aim to develope novel breath markers of gestational diabetes through a prospective high-risk population cohort study and achieve early prediction of gestational diabetes based on an interpretable machine learning model.
- Conditions
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gestational Diabetes Group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of gestational diabetes mellitus
Measured: 24-28 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start25 Dec 2024
- Primary completionMar 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Central Hospital of Gynecology Obstetrics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753734
- Sponsor's protocol ID
- 2024KY081
- Status last verified
- Dec 2024
- First submitted
- 23 Dec 2024
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study in Women at High Risk for Gestational Diabetes Based on Breath Metabolomics
- ClinicalTrials.gov ID
- NCT06753734
- Acronym / sponsor ID
- 2024KY081
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Tianjin Central Hospital of Gynecology ObstetricsUniversity, hospital or other
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Dec 2024 (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.
This study aim to develope novel breath markers of gestational diabetes through a prospective high-risk population cohort study and achieve early prediction of gestational diabetes based on an interpretable machine learning model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational Diabetes Group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population in this study include pregnant women aged 18-55 years and at 11-14 weeks gestation with at least one risk factor for GDM
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Diabetes mellitus or abnormal glucose metabolism before pregnancy
- Hyperemesis gravidarum (urine ketone positive))
- Thyroid dysfunction
- Asthmatic patients
- Hypertensive diseases that are difficult to control
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of gestational diabetes mellitus
Time frame: 24-28 weeks gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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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.
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?
An observational study of Gestational Diabetes, run by Tianjin Central Hospital of Gynecology Obstetrics at 1 site in China.
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 0 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 31 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of gestational diabetes mellitus (time frame: 24-28 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2025.