Correlation Between Environmental Pollution and Gestational Diabetes Mellitus

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Other: Clinical data and specimen collection

• Study Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Zhaoxia Liang, Prof.; Phone Number: 86571-89992115; Email: xiaozaizai@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Women's Hospital School Of Medicine Zhejiang University
      • Contact: Zhaoxia Liang, Prof.; Phone Number: 86571-89992115; Email: xiaozaizai@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GDM group; Pregnant women with positive OGTT results at 24-28 gestational weeks	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.
Control group; Pregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 15, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: Environment2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No