Study on Serum Metabolomics of GDM

Zhejiang University

Status: Enrolling

Conditions: GDM; Diagnosis; Pathogenesis

Treatments: Other: Specimen samples and baseline data collection

Study type: Observational

Funder types: Other

Identifiers

NCT05881616

IRB-20230193-R

Details and patient eligibility

About

This study aims to collect serum samples from healthy non-pregnant women, pregnant women with and without Gestational Diabetes Mellitus (GDM). We will analyze the metabolite changes among the three groups using clinical metabolomics and identify potential biomarkers and metabolic pathways. This study will provide scientific evidence for early clinical diagnosis, prevention, control, and treatment research of GDM.

Enrollment: 480 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No obvious abnormalities in all inspection items
• No history of diabetes
• No particular dietary habits
• No previous history of other mental illnesses
• No history of drug abuse or allergies
• No history of smoking or drinking

Exclusion criteria

• Pregnancy complications such as uterine fibroids, hyperthyroidism/hypothyroidism, and antiphospholipid antibody syndrome
• Critical illnesses such as cardiovascular disease or abnormal liver/kidney function
• Personal history of syphilis, HIV positive, and other infectious diseases
• Artificial insemination or IVF pregnancy
• Multiple pregnancy (twins or more)
• Patients participating in other clinical studies
• Other reasons that researchers think are inappropriate

Trial design

480 participants in 3 patient groups

GDM group

Description:

Pregnant women aged 20-40 with positive oral glucose tolerance test (OGTT) results at 24-28 weeks.

Treatment:

Other: Specimen samples and baseline data collection

Other: Specimen samples and baseline data collection

Other: Specimen samples and baseline data collection

non-GDM group

Description:

Pregnant women aged 20-40 with negative OGTT results at 24-28 weeks.

Treatment:

Other: Specimen samples and baseline data collection

Other: Specimen samples and baseline data collection

Other: Specimen samples and baseline data collection

Control group

Description:

Healthy non-pregnant women aged 20-40.

Treatment:

Other: Specimen samples and baseline data collection

Other: Specimen samples and baseline data collection

Other: Specimen samples and baseline data collection