Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-31 @ 2:10 AM
Study NCT ID:
NCT05733195
Status:
UNKNOWN
Last Update Posted:
2023-02-17
First Post:
2022-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Biomarker in Early Diagnosis of GDM by Metabolomics
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
The Study of Biomarker in Early Diagnosis of Gestational Diabetes Mellitus by Metabolomics
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GDM
Brief Summary:
Gestational Diabetes Mellitus (GDM) refers to abnormal glucose metabolism during pregnancy, in which elevated blood glucose is first found during pregnancy and meets the criteria for diabetes. In recent years, with the increase of obese women of childbearing age, the incidence of GDM has been rising, the current global average incidence is about 14%, and the incidence in China has increased from 2% in 1999 to 5%-8% at present. If one-step diagnosis is used, the rate will be between 13%-17%, which will greatly increase the social burden. Gestational diabetes mellitus (GDM) significantly increases the risk of diseases for pregnant women and infants, such as abortion and premature delivery, concurrent hypertension, concurrent infection, metabolic disorders, postpartum diabetes, macrosomia, fetal malformation, neonatal hypoglycemia, neonatal respiratory distress syndrome, and so on. It is one of the important public health problems threatening human health. Therefore, the accurate diagnosis of GDM is of great clinical significance for the timely formulation of intervention and treatment measures, reducing the risk of maternal and infant diseases and improving the level of public health.
Detailed Description:
The study will follow a prospective cohort design and be conducted in Peking Union Medical College Hospital. All basic information was collected in the first trimester, and all subjects underwent OGTT (75g glucose) at 24-28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG. At four time points during pregnancy (6-13 weeks, 24-28 weeks, 36-weeks before delivery, and 6 weeks after delivery), blood samples of 5ml were collected from each subject at each time point without increasing the number of blood samples. In the GDM group, blood samples were collected at the same time during routine visit 6 weeks after delivery. The relevant broad metabolomics and targeted vitamin profiles were also detected. Meanwhile, blood glucose values at the corresponding time points were collected. Using these variables, we will combine the metabolomics information to screen a predictive marker for GDM in Chinese reproductive age population.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: