Gestational DiabetesNCT05992974
To Identify Urinary Biomarkers Associated With Gestational Diabetes Mellitus [GDM]
An observational study of Gestational Diabetes, run by Peking Union Medical College Hospital at 2 sites in China.
Trial summary
Gestational diabetes mellitus(GDM) is one of the most common complications of pregnancy. The incidence of GDM is higher in Asian than in other regions, and GDM can increase the risk of a series of perinatal complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- How many people
- 1,000 participants
- Where
- 2 sitesChina
- Study dates
- 31 Aug 2023to Dec 2025
- 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 years and older
- Women only
- Adult, Older adult
Study population: Our study population was pregnant women in early pregnancy who regularly visited the following two medical center: Mudanjiang First People's Hospital, and Mudanjiang Maternal and Child Health Care Hospital. All pregnant women within 12 gestational weeks are eligible for enrollment, and whether entry or not depends on their own preference. There were no requirements for household registration, place of residence, and other identify informations of the enrolled women.
Who may be able to join
- Women of childbearing age who are in early pregnancy(gestational age less than 12 weeks);
- Regular prenatal examination until delivery;
- Older than 18 years old;
- Obtained informed consent from participants and/or their family members.
Who cannot join
- Twins or multiple pregnancy;
- With impaired glucose tolerance or diabetes mellitus before pregnancy;
- With severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy);
- Medications other than vitamins used during pregnancy;
- Inability to understand and follow-up regularly;
- Other conditions that were judged by the investigator to be ineligible for participation in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Mudanjiang First People's Hospital
Mudanjiang, Heilongjiang
Yanbei Duo, Dr., 86+15561852093
- Recruiting
Mudanjiang Maternal and Child Health Hospital
Mudanjiang, Heilongjiang
Yanbei Duo, 86+15561852093, duoduo15561852093@163.com
About this study
Official title: To Identify Urinary Biomarkers in the First Trimester Associated With Gestational Diabetes Mellitus [GDM] and Achieve Early Diagnosis of GDM Using Urinary Proteomic Analysis: An Observational Study
Gestational diabetes mellitus(GDM) is one of the most common complications of pregnancy. The incidence of GDM is higher in Asian than in other regions, and GDM can increase the risk of a series of perinatal complications. The investigators has been committed to the early diagnosis of GDM, and several biomarkers in the first trimester and urinary proteomic markers that were associated with GDM have been found. Based on the previous work, the aim of this study was to verify the predictive ability of urinary proteomic markers for GDM that has been found in the previous study of the researchers. This study is a multi-center, prospective, and observational study. Urine samples will be collected twice, at 12 weeks and 24-28 weeks of gestation, respectively.
Read the detailed description
The eligibility criteria are as follows:
- singleton pregnant women over 18 years old;
- gestational age less than 12 weeks;
- regular follow-up until delivery;
- able to understand and sign an informed consent.
The exclusion criteria of pregnant women are as follows:
- with impaired glucose tolerance or diabetes mellitus before pregnancy;
- severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy);
- medications other than vitamins used during pregnancy;
- inability to understand and follow-up regularly;
- other conditions judged by the investigators to be inappropriate for participation in the study.
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, urinary proteomics, early prediction
- Medical subject headings
- Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with gestational diabetes
Diagnosed by 75g-OGTT at 24-28 weeks of gestation. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criterion in 2010: fasting blood glucose ≥5.1mmol/L, and/or 1-hour blood glucose ≥10.0mmol/L, and/or 2-hour blood glucose ≥8.5mmol/L
Measured: at 24-28 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start31 Aug 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mudanjiang First People's Hospital, Mudanjiang Maternal and Child Health Hospital
- Responsible party
- Sponsor
- Investigators
- Tedros Adhanom Ghebreyesus, Principal investigator, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992974
- Sponsor's protocol ID
- 202303075GDM
- Other IDs
- K4087
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang X, Zhao M, Guo Z, Song S, Liu S, Yuan T, Fu Y, Dong Y, Sun H, Liu X, Zhou D, Zhao W, Sun W. Urinary proteomic analysis during pregnancy and its potential application in early prediction of gestational diabetes mellitus and spontaneous abortion. Ann Transl Med. 2022 Jul;10(13):736. doi: 10.21037/atm-21-3497.
PubMed 35957715Song S, Duo Y, 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. The Predictive Ability of Hepatic Steatosis Index for Gestational Diabetes Mellitus and Large for Gestational Age Infant Compared with Other Noninvasive Indices Among Chinese Pregnancies: A Preliminary Double-center Cohort Study. Diabetes Metab Syndr Obes. 2021 Dec 16;14:4791-4800. doi: 10.2147/DMSO.S335364. eCollection 2021.
PubMed 34938090Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Lu Z, Liu S, Zhao T, Yuan T, Fu Y, Dong Y, Zhao W, Sun W, Wang A. HOMA-IR as a risk factor of gestational diabetes mellitus and a novel simple surrogate index in early pregnancy. Int J Gynaecol Obstet. 2022 Jun;157(3):694-701. doi: 10.1002/ijgo.13905. Epub 2021 Sep 24.
PubMed 34449903Duo 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. Predictability of HOMA-IR for Gestational Diabetes Mellitus in Early Pregnancy Based on Different First Trimester BMI Values. J Pers Med. 2022 Dec 28;13(1):60. doi: 10.3390/jpm13010060.
PubMed 36675721Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Wang A, Lu Z, Sun W, Fu Y, Dong Y, Yuan T, Zhao W. ALT/AST as an Independent Risk Factor of Gestational Diabetes Mellitus Compared with TG/HDL-C. Int J Gen Med. 2022 Jan 5;15:115-121. doi: 10.2147/IJGM.S332946. eCollection 2022.
PubMed 35023950
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Identify Urinary Biomarkers in the First Trimester Associated With Gestational Diabetes Mellitus [GDM] and Achieve Early Diagnosis of GDM Using Urinary Proteomic Analysis: An Observational Study
- ClinicalTrials.gov ID
- NCT05992974
- Acronym / sponsor ID
- 202303075GDM
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, urinary proteomics, early prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Mudanjiang First People's Hospital, Mudanjiang Maternal and Child Health Hospital
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Aug 2023 (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) is one of the most common complications of pregnancy. The incidence of GDM is higher in Asian than in other regions, and GDM can increase the risk of a series of perinatal complications. The investigators has been committed to the early diagnosis of GDM, and several biomarkers in the first trimester and urinary proteomic markers that were associated with GDM have been found. Based on the previous work, the aim of this study was to verify the predictive ability of urinary proteomic markers for GDM that has been found in the previous study of the researchers. This study is a multi-center, prospective, and observational study. Urine samples will be collected twice, at 12 weeks and 24-28 weeks of gestation, respectively.
Detailed description
The eligibility criteria are as follows:
- singleton pregnant women over 18 years old;
- gestational age less than 12 weeks;
- regular follow-up until delivery;
- able to understand and sign an informed consent.
The exclusion criteria of pregnant women are as follows:
- with impaired glucose tolerance or diabetes mellitus before pregnancy;
- severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy);
- medications other than vitamins used during pregnancy;
- inability to understand and follow-up regularly;
- other conditions judged by the investigators to be inappropriate for participation in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Our study population was pregnant women in early pregnancy who regularly visited the following two medical center: Mudanjiang First People's Hospital, and Mudanjiang Maternal and Child Health Care Hospital. All pregnant women within 12 gestational weeks are eligible for enrollment, and whether entry or not depends on their own preference. There were no requirements for household registration, place of residence, and other identify informations of the enrolled women.
Key inclusion criteria (4 listed)
- Women of childbearing age who are in early pregnancy(gestational age less than 12 weeks);
- Regular prenatal examination until delivery;
- Older than 18 years old;
- Obtained informed consent from participants and/or their family members.
Key exclusion criteria (6 listed)
- Twins or multiple pregnancy;
- With impaired glucose tolerance or diabetes mellitus before pregnancy;
- With severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy);
- Medications other than vitamins used during pregnancy;
- Inability to understand and follow-up regularly;
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
Number of participants with gestational diabetes
Time frame: at 24-28 weeks of gestation
Diagnosed by 75g-OGTT at 24-28 weeks of gestation. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criterion in 2010: fasting blood glucose ≥5.1mmol/L, and/or 1-hour blood glucose ≥10.0mmol/L, and/or 2-hour blood glucose ≥8.5mmol/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Results publication: PubMed 35957715Wang X, Zhao M, Guo Z, Song S, Liu S, Yuan T, Fu Y, Dong Y, Sun H, Liu X, Zhou D, Zhao W, Sun W. Urinary proteomic analysis during pregnancy and its potential application in early prediction of gestational diabetes mellitus and spontaneous abortion. Ann Transl Med. 2022 Jul;10(13):736. doi: 10.21037/atm-21-3497.
- Results publication: PubMed 34938090Song S, Duo Y, 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. The Predictive Ability of Hepatic Steatosis Index for Gestational Diabetes Mellitus and Large for Gestational Age Infant Compared with Other Noninvasive Indices Among Chinese Pregnancies: A Preliminary Double-center Cohort Study. Diabetes Metab Syndr Obes. 2021 Dec 16;14:4791-4800. doi: 10.2147/DMSO.S335364. eCollection 2021.
- Results publication: PubMed 34449903Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Lu Z, Liu S, Zhao T, Yuan T, Fu Y, Dong Y, Zhao W, Sun W, Wang A. HOMA-IR as a risk factor of gestational diabetes mellitus and a novel simple surrogate index in early pregnancy. Int J Gynaecol Obstet. 2022 Jun;157(3):694-701. doi: 10.1002/ijgo.13905. Epub 2021 Sep 24.
- Results publication: PubMed 36675721Duo 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. Predictability of HOMA-IR for Gestational Diabetes Mellitus in Early Pregnancy Based on Different First Trimester BMI Values. J Pers Med. 2022 Dec 28;13(1):60. doi: 10.3390/jpm13010060.
- Results publication: PubMed 35023950Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Wang A, Lu Z, Sun W, Fu Y, Dong Y, Yuan T, Zhao W. ALT/AST as an Independent Risk Factor of Gestational Diabetes Mellitus Compared with TG/HDL-C. Int J Gen Med. 2022 Jan 5;15:115-121. doi: 10.2147/IJGM.S332946. eCollection 2022.
- 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.
Tedros Adhanom Ghebreyesus principal investigator
World Health Organization
2 sites 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 Peking Union Medical College Hospital at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yanbei Duo, Dr. (86+15561852093, duoduo15561852093@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with gestational diabetes (time frame: at 24-28 weeks of gestation). 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 NCT05992974, which also lists 5 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 3 Oct 2023.