Study on Serum Metabolomics of GDM

Diagnosis Clinical Trial

Official title:

Serum Metabolomics Analysis for Early Diagnosis and Pathogenesis of Gestational Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881616
• Other study ID #: IRB-20230193-R
• Status: Recruiting
• Start date: July 18, 2023
• Est. completion date: May 2026

Study information

• Verified date: July 2023
• Source: Zhejiang University
• Contact: LI Lu, Dr.
• Phone: 0571-88208596
• Email: luciali[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diagnosis
• Disease
• GDM
• Pathogenesis

Intervention

Other:
• Specimen samples and baseline data collection
The remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age.
• Specimen samples and baseline data collection
The remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age.
• Specimen samples and baseline data collection
The remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Content of serum metabolomics	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.	Second trimester (24-28 gestational weeks)