Study on Serum Metabolomics of GDM

NCT05881616 | Recruiting

• 1 other identifier: IRB-20230193-R
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

GDM; Pathogenesis; Diagnosis

Keywords

Metabolomics

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

GDM group

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

Other: Specimen samples and baseline data collection

non-GDM group

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

Other: Specimen samples and baseline data collection

Control group

Healthy non-pregnant women aged 20-40.

Other: Specimen samples and baseline data collection

Interventions

Specimen samples and baseline data collection 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.

GDM group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study aims to recruit pregnant women undergoing routine prenatal examinations and healthy women undergoing routine physical examination.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang University: lead
• Women's Hospital School Of Medicine Zhejiang University: collaborator

Study Sites (1)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

LI Lu, Dr.

CONTACT

0571-88208596; luciali@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: May 31, 2023
• Study Start: July 18, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

CN (1)