Correlation Between Environmental Pollution and Gestational Diabetes Mellitus

Gestational Diabetes Mellitus Clinical Trial

Official title:

Correlation Between Environmental Pollution and Gestational Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388721
• Other study ID #: Environment2022
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Zhaoxia Liang, Prof.
• Phone: 86571-89992115
• Email: xiaozaizai[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gestational diabetes mellitus (GDM) refers to the abnormal glucose metabolism index of pregnant women during pregnancy. At present, about 15% of pregnant women will develop GDM in the second and third trimester, which seriously affects the health of the pregnant woman and the fetus. However, the etiology of GDM remains unclear. Various pollutants in the environment may have a potential impact on pregnant women and fetuses. For example, previous studies have shown that exposure to atmospheric pollutants nitric oxide and organochlorine pesticides are associated with GDM. At present, we plan to further investigate the correlation between environmental pollutants and GDM.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

Inclusion Criteria:

• Plan to complete OGTT and give birth in the research center

• First trimester

• Singleton pregnancy

• Without diabetes before pregnancy

Exclusion Criteria:

• Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.

• Fetus has a known deformity or genetic defects

• Incomplete clinical data

• Assisted reproductive

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Other:
• Clinical data and specimen collection
Questionnaire survey and clinical data was conducted when pregnant women were enrolled in the first trimester, and blood and urine were collected. Furthermore, we will follow up the pregnant women until delivery, blood and urine were collected during the third trimester (after 28 weeks), and clinical information was collected. Umbilical cord blood and placental tissue will be collected if possible.

Locations

Country	Name	City	State
China	Women's Hospital School Of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Environmental contaminants 1	The concentrations of environmental pollutants, such as organochlorine pesticides, polychlorinated biphenyls, polycyclic aromatic hydrocarbons, polybrominated diphenyl ethers and metallic elements, in serum and urine were analyzed by gas chromatochromatograms and mass spectrometry (GC-MS/MS). Specimens were collected during the first trimester and tested when classified in the GDM or control group	First trimester (9-14 gestational weeks)
Primary	Environmental contaminants 2	The concentrations of environmental pollutants, such as organochlorine pesticides, polychlorinated biphenyls, polycyclic aromatic hydrocarbons, polybrominated diphenyl ethers and metallic elements, in serum and urine were analyzed by gas chromatochromatograms and mass spectrometry (GC-MS/MS). Specimens were collected during the third trimester.	Third trimester (after 28 gestational weeks)