Study on Serum Metabolomics of GDM

Recruiting

• Conditions: GDM; Diagnosis; Pathogenesis
• Interventions: Other: Specimen samples and baseline data collection

• Registration Number: NCT05881616
• Lead Sponsor: Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-19
• Study First Submitted QC: 2023-05-27
• Study First Posted: 2023-05-31
• Status Verified: 2023-07
• Study Start: 2023-07-18
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-24
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 480

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GDM group	Specimen samples and baseline data collection	Pregnant women aged 20-40 with positive oral glucose tolerance test (OGTT) results at 24-28 weeks.
non-GDM group	Specimen samples and baseline data collection	Pregnant women aged 20-40 with negative OGTT results at 24-28 weeks.
Control group	Specimen samples and baseline data collection	Healthy non-pregnant women aged 20-40.

Primary Outcome Measures

Name	Time	Method
Content of serum metabolomics	Second trimester (24-28 gestational weeks)	Based on non-targeted metabolomics technology, the metabolites in serum were comprehensively detected. Differential metabolites were screened using multivariate statistical analysis. Then quantitatively detect the content of these metabolites to find the differential metabolites with predictive ability for GDM.

Trial Locations

Locations (1)

Women's Hospital School Of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China