GDMNCT05078697
Multiomics-based Prediction Model for GDM
An observational study of GDM, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
A prospective cohort study was conducted to :1. explore the relative biomarkers of related with the occurence and development; 2. develop a multiotimics prediction model for GDM. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- GDM
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Mar 2023
- How long will I take part?
- 10 Months
- Phase
- Observational
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: 60 pregnant women who has high risk for GDM and 40 normal will be enrolled in this study.
Who may be able to join
- All of following conditions must be met:
- The range of pregnant week is between 8 to 13+6 weeks;
- The range of age is between 20 to 45 years;
- Pregnancy naturally and singleton pregnancy;
- According to the 2020 GDM high-risk population scoring model, those who gets equal to or larger than 80 scores will be assigned to high-risk group and equal to or smaller than 20 scores to low-risk group;
Who cannot join
- Meeting one of the following conditions will be excluded:
- Smoking or drinking alcohols;
- Pregnant women who used antibiotics before 1 month enrollment;
- Combined with Chronic hepatitis, nephritis, chronic gastritis, gastric ulcer, chronic colitis, hyperthyroidism, hypothyroidism (except subclinical hypothyroidism) and blood diseases before pregnancy;
- Pregnant women who has a long-term medication history;
- Those who reject signing the inform consent;
- Those who has participated other clinical trail in the same period
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of ob gyn , Peking Union Medical College Hospital
Beijing, Beijing Municipality
Liangkun Ma, 13021961166, MaLiangKun@pumch.cn
Suhan Zhang, 18611967191, hanhan1114@126.com
About this study
Official title: Exploratory Study on Gestational Diabetes Mellitus: Multiomics-based Prediction Model
A prospective cohort study was conducted to :1. explore the relative biomarkers of related with the occurence and development; 2. develop a multiotimics prediction model for GDM.
Read the detailed description
Gestational diabetes mellitus (GDM) is one of the most complications during pregnancy and it is associated with many adverse outcomes especially when the pregnant women can't control blood glucose well. With economy develop rapidly, the occurence of GDM is about 15-20%. Recently, the research on GDM has gone into the molecular level, which is beneficial to diagnosis and treatment on GDM. Besides, the cost of hospitalization and treatment for adverse outcomes caused by GDM have caused a certain burden to pregnant women, their families and the whole country. Lifestyle management has the first-line for treatment on GDM, however, the situation of self-management on GDM isn't satisfactory. Therefore, our study aims to explore a model to predict GDM in advance and reduce the adverse outcomes and economy associated with GDM.
The study plan to enroll 60 participants with hisk-risk of GDM and 40 normal participants. They are required sign the inform consent after deciding to participate the research. Furthermore, during early pregnancy (8-13 weeks), middle pregnancy (24-27 3 weeks) and late pregnancy (32-36 weeks), 6-8 weeks after delivery, blood, feces, urine, saliva samples were collected, and continuous blood glucose monitoring system were equipped, human component testing was performed. Follow up was performed to collect the first stool sample of the mother after delivery and faecal samples from the first to the fifth time after birth (the first five times within one week after birth, including hospitalization and discharge) .
- Conditions
- GDM
- Keywords
- GDM, predictive model, multiotimics
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 |
|---|---|---|
| early pregnancy women | According to the 2020 high-risk population score model, participants with high risks for GDM and normal health participants will be enrolled into the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiota
1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value
Measured: At 8 to 13 gestational weeks
microbiota
1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value
Measured: At 24 to 28 gestational weeks
microbiota
1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value
Measured: At 32-36 gestational weeks
microbiota
1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value; 4. The composition of gut in fetuses
Measured: At postpartum 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangkun Ma, Study chair, Chinese Academic of Medical Science & Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078697
- Sponsor's protocol ID
- HS-2297
- Status last verified
- May 2021
- First submitted
- 3 Sep 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on Gestational Diabetes Mellitus: Multiomics-based Prediction Model
- ClinicalTrials.gov ID
- NCT05078697
- Acronym / sponsor ID
- HS-2297
- Conditions
- GDM
- Keywords
- GDM, predictive model, multiotimics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 14 Oct 2021 (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.
A prospective cohort study was conducted to :1. explore the relative biomarkers of related with the occurence and development; 2. develop a multiotimics prediction model for GDM.
Detailed description
Gestational diabetes mellitus (GDM) is one of the most complications during pregnancy and it is associated with many adverse outcomes especially when the pregnant women can't control blood glucose well. With economy develop rapidly, the occurence of GDM is about 15-20%. Recently, the research on GDM has gone into the molecular level, which is beneficial to diagnosis and treatment on GDM. Besides, the cost of hospitalization and treatment for adverse outcomes caused by GDM have caused a certain burden to pregnant women, their families and the whole country. Lifestyle management has the first-line for treatment on GDM, however, the situation of self-management on GDM isn't satisfactory. Therefore, our study aims to explore a model to predict GDM in advance and reduce the adverse outcomes and economy associated with GDM.
The study plan to enroll 60 participants with hisk-risk of GDM and 40 normal participants. They are required sign the inform consent after deciding to participate the research. Furthermore, during early pregnancy (8-13 weeks), middle pregnancy (24-27 3 weeks) and late pregnancy (32-36 weeks), 6-8 weeks after delivery, blood, feces, urine, saliva samples were collected, and continuous blood glucose monitoring system were equipped, human component testing was performed. Follow up was performed to collect the first stool sample of the mother after delivery and faecal samples from the first to the fifth time after birth (the first five times within one week after birth, including hospitalization and discharge) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| early pregnancy women | – | –According to the 2020 high-risk population score model, participants with high risks for GDM and normal health participants will be enrolled into the study. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 60 pregnant women who has high risk for GDM and 40 normal will be enrolled in this study.
Key inclusion criteria (5 listed)
- The range of pregnant week is between 8 to 13+6 weeks;
- The range of age is between 20 to 45 years;
- Pregnancy naturally and singleton pregnancy;
- According to the 2020 GDM high-risk population scoring model, those who gets equal to or larger than 80 scores will be assigned to high-risk group and equal to or smaller than 20 scores to low-risk group;
Key exclusion criteria (7 listed)
- Smoking or drinking alcohols;
- Pregnant women who used antibiotics before 1 month enrollment;
- Combined with Chronic hepatitis, nephritis, chronic gastritis, gastric ulcer, chronic colitis, hyperthyroidism, hypothyroidism (except subclinical hypothyroidism) and blood diseases before pregnancy;
- Pregnant women who has a long-term medication history;
- Those who reject signing the inform consent;
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
microbiota
Time frame: At 8 to 13 gestational weeks
1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value
microbiota
Time frame: At 24 to 28 gestational weeks
1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value
microbiota
Time frame: At 32-36 gestational weeks
1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value
microbiota
Time frame: At postpartum 42 days
1.The composition of gut and saliva microbiota in women;2. The blood glucose level;3. The body composition value; 4. The composition of gut in fetuses
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for GDM
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Diabetes, Insulin, Gut, Enteric Supplementation Trial
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Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus
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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.
Liangkun Ma study chair
Chinese Academic of Medical Science & Peking Union Medical College Hospital
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 GDM, run by Peking Union Medical College Hospital 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liangkun Ma (13021961166, MaLiangKun@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiota (time frame: At 8 to 13 gestational weeks). The study lists 4 primary outcomes in all. 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 14 Oct 2021; AzTrials last refreshed its copy on 29 Oct 2026.