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Study on Serum Metabolomics of GDM

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05881616
Enrollment
480
Registered
2023-05-31
Start date
2023-07-18
Completion date
2026-05-31
Last updated
2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis, GDM, Pathogenesis

Keywords

Metabolomics

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.

Interventions

OTHERSpecimen 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.

Sponsors

Women's Hospital School Of Medicine Zhejiang University
CollaboratorOTHER
Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Content of serum metabolomicsSecond 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.

Countries

China

Contacts

Primary ContactLI Lu, Dr.
luciali@zju.edu.cn0571-88208596

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026