Study on Serum Metabolomics of GDM

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

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.

Study Overview

• Status: Recruiting
• Conditions: Diagnosis; Pathogenesis; GDM
• Intervention / Treatment: Other: Specimen samples and baseline data collection

• Study Type: Observational
• Enrollment (Estimated): 480

Contacts and Locations

• Study Contact: Name: LI Lu, Dr.; Phone Number: 0571-88208596; Email: luciali@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Women's Hospital School of Medicine Zhejiang University
      • Contact: HU Xiaoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	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.
Control group; Healthy non-pregnant women aged 20-40.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Women's Hospital School Of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: May 27, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Metabolomics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: IRB-20230193-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No