Gestational Diabetes MellitusNCT03246295
Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis
An observational study of Gestational Diabetes Mellitus, run by Peking Union Medical College Hospital.
Trial summary
Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses. At present, no prediction marker for GDM in early pregnancy is accepted. There is still a lack of recognized early predictors. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- lifestyle intervention or insulin treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2015to 1 Oct 2017
- 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 18 to 45 years
- Women only
- Adult
Study population: Pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum
Who may be able to join
- -Pregnant women （<12 weeks）
Who cannot join
- with renal dysfunction
- urine routine examination abnormalities for twice
- history of urinary and reproductive system diseases
- with other chronic diseases
About this study
Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses. At present, no prediction marker for GDM in early pregnancy is accepted. There is still a lack of recognized early predictors. This study was designed to identity valuable biomarkers for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed according to the latest ADA standard. Urinary samples were collected in the first (<12 weeks), second (24~28 weeks) and third (32~weeks) trimester of pregnancy. Urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal analysis; 15 cases of GDM women and 15 cases of age matched control women were used for difference analysis.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- lifestyle intervention or insulin treatment
- Keywords
- Proteomics, Metabolomics
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle intervention or insulin treatmentOther
Firstly，the gestational diabetes mellitus（GDM） women were treated with lifestyle intervention.Those women were treated with insulin if their blood glucose was not well Controled.
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabetes mellitus | Those women were diagnosed as gestational diabetes mellitus Receives: Other: lifestyle intervention or insulin treatment | |
| Control | Those women were diagnosed without gestational diabetes mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary samples were analyzed
Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.
Measured: in the first (<12 weeks) trimester of pregnancy
Secondary outcomes (2)
Urinary samples were analyzed
Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.
Measured: in the second (24-28 weeks) trimester of pregnancy
Urinary samples were analyzed
Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.
Measured: in the third (>32 weeks) trimester of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start20 Oct 2015
- Primary completion1 Sep 2017 (estimated)
- Study completion1 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wuxueyan, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246295
- Sponsor's protocol ID
- ZS976
- Status last verified
- Aug 2017
- First submitted
- 23 Jul 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duo Y, Song S, Qiao X, Zhang Y, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. A Simplified Screening Model to Predict the Risk of Gestational Diabetes Mellitus in Pregnant Chinese Women. Diabetes Ther. 2023 Dec;14(12):2143-2157. doi: 10.1007/s13300-023-01480-8. Epub 2023 Oct 16.
PubMed 37843770Duo Y, Song S, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. Relationship between serum uric acid in early pregnancy and gestational diabetes mellitus: a prospective cohort study. Endocrine. 2024 Mar;83(3):636-647. doi: 10.1007/s12020-023-03544-y. Epub 2023 Oct 2.
PubMed 37782356Liu X, Wang X, Sun H, Guo Z, Liu X, Yuan T, Fu Y, Tang X, Li J, Sun W, Zhao W. Urinary metabolic variation analysis during pregnancy and application in Gestational Diabetes Mellitus and spontaneous abortion biomarker discovery. Sci Rep. 2019 Feb 22;9(1):2605. doi: 10.1038/s41598-019-39259-2.
PubMed 30796299
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis
- ClinicalTrials.gov ID
- NCT03246295
- Acronym / sponsor ID
- ZS976
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Proteomics, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 11 Aug 2017 (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.
Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses. At present, no prediction marker for GDM in early pregnancy is accepted. There is still a lack of recognized early predictors. This study was designed to identity valuable biomarkers for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed according to the latest ADA standard. Urinary samples were collected in the first (<12 weeks), second (24~28 weeks) and third (32~weeks) trimester of pregnancy. Urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal analysis; 15 cases of GDM women and 15 cases of age matched control women were used for difference analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes mellitus | – | Other: lifestyle intervention or insulin treatmentThose women were diagnosed as gestational diabetes mellitus |
| Control | – | –Those women were diagnosed without gestational diabetes mellitus |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum
Key inclusion criteria (1 listed)
- -Pregnant women （<12 weeks）
Key exclusion criteria (4 listed)
- with renal dysfunction
- urine routine examination abnormalities for twice
- history of urinary and reproductive system diseases
- with other chronic diseases
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 |
|---|---|---|
| lifestyle intervention or insulin treatmentFirstly，the gestational diabetes mellitus（GDM） women were treated with lifestyle intervention.Those women were treated with insulin if their blood glucose was not well Controled. | Other | Gestational diabetes mellitus |
Primary outcome
Urinary samples were analyzed
Time frame: in the first (<12 weeks) trimester of pregnancy
Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.
2 secondary outcomes
Urinary samples were analyzed
Time frame: in the second (24-28 weeks) trimester of pregnancy
Urinary samples were analyzed
Time frame: in the third (>32 weeks) trimester of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Derived from this study: PubMed 37843770Duo Y, Song S, Qiao X, Zhang Y, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. A Simplified Screening Model to Predict the Risk of Gestational Diabetes Mellitus in Pregnant Chinese Women. Diabetes Ther. 2023 Dec;14(12):2143-2157. doi: 10.1007/s13300-023-01480-8. Epub 2023 Oct 16.
- Derived from this study: PubMed 37782356Duo Y, Song S, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. Relationship between serum uric acid in early pregnancy and gestational diabetes mellitus: a prospective cohort study. Endocrine. 2024 Mar;83(3):636-647. doi: 10.1007/s12020-023-03544-y. Epub 2023 Oct 2.
- Derived from this study: PubMed 30796299Liu X, Wang X, Sun H, Guo Z, Liu X, Yuan T, Fu Y, Tang X, Li J, Sun W, Zhao W. Urinary metabolic variation analysis during pregnancy and application in Gestational Diabetes Mellitus and spontaneous abortion biomarker discovery. Sci Rep. 2019 Feb 22;9(1):2605. doi: 10.1038/s41598-019-39259-2.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus, run by Peking Union Medical College Hospital.
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 1 inclusion and 4 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 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Urinary samples were analyzed (time frame: in the first (<12 weeks) trimester of pregnancy). 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 NCT03246295, which also lists 3 linked publications.
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 11 Aug 2017.