Correlation Between Environmental Pollution and Gestational Diabetes Mellitus

NCT05388721 | Unknown

• 1 other identifier: Environment2022
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

GDM group

Pregnant women with positive OGTT results at 24-28 gestational weeks

Other: Clinical data and specimen collection

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

Interventions

Clinical data and specimen collection OTHER

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; GDM group

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Plan to complete OGTT and give birth in the research center
• First trimester
• Singleton pregnancy
• Without diabetes before pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, urine

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Zhaoxia Liang, Prof.

CONTACT

86571-89992115; xiaozaizai@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: May 24, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

CN (1)