Identifying urinary biomarkers for gestational diabetes
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
This study is trying to find specific substances in urine that can help predict gestational diabetes in pregnant women during their early pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 2 sites (Mudanjiang, Heilongjiang and 1 other locations) |
| Trial ID | NCT05992974 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify urinary proteomic biomarkers associated with gestational diabetes mellitus (GDM) in pregnant women. It will involve collecting urine samples from participants at two points during their pregnancy: at 12 weeks and again at 24-28 weeks. The study focuses on women who are in early pregnancy and will monitor their health until delivery. The goal is to verify the predictive ability of previously identified biomarkers for GDM.
Who should consider this trial
Good fit: Ideal candidates for this study are singleton pregnant women over 18 years old who are less than 12 weeks pregnant and can commit to regular follow-up until delivery.
Not a fit: Patients with pre-existing diabetes or severe chronic diseases prior to pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of gestational diabetes, improving maternal and fetal health outcomes.
How similar studies have performed: Previous studies have shown promise in identifying biomarkers for gestational diabetes, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Mudanjiang, Heilongjiang and 1 other locations
- Mudanjiang First People's Hospital — Mudanjiang, Heilongjiang, China (Recruiting)
- Mudanjiang Maternal and Child Health Hospital — Mudanjiang, Heilongjiang, China (Recruiting)
Study contacts
- Principal investigator: Tedros Adhanom Ghebreyesus — World Health Organization
- Study coordinator: Yanbei Duo, Dr.
- Email: duoduo15561852093@163.com
- Phone: 86+15561852093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.