Study on Serum Metabolomics of GDM

NCT ID: NCT05881616

Last Updated: 2023-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-18

Study Completion Date

2026-05-31

Brief Summary

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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

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Conditions

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GDM Pathogenesis Diagnosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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GDM group

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

Specimen samples and baseline data collection

Intervention Type OTHER

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.

non-GDM group

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

Specimen samples and baseline data collection

Intervention Type OTHER

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.

Control group

Healthy non-pregnant women aged 20-40.

Specimen samples and baseline data collection

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Lu LI

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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LI Lu, Dr.

Role: CONTACT

0571-88208596

Facility Contacts

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HU Xiaoli

Role: primary

Other Identifiers

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IRB-20230193-R

Identifier Type: -

Identifier Source: org_study_id

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