RecruitingNCT05881616

Study on Serum Metabolomics of GDM

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


Sponsor

Zhejiang University

Enrollment

480 participants

Start Date

Jul 18, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 40 Years

Inclusion Criteria6

  • 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 Criteria7

  • 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

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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.

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.

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.


Locations(1)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

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NCT05881616


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