The Study of Biomarker in Early Diagnosis of GDM by Metabolomics (GDM)

The Study of Biomarker in Early Diagnosis of Gestational Diabetes Mellitus by Metabolomics

Gestational Diabetes Mellitus (GDM) refers to abnormal glucose metabolism during pregnancy, in which elevated blood glucose is first found during pregnancy and meets the criteria for diabetes. In recent years, with the increase of obese women of childbearing age, the incidence of GDM has been rising, the current global average incidence is about 14%, and the incidence in China has increased from 2% in 1999 to 5%-8% at present. If one-step diagnosis is used, the rate will be between 13%-17%, which will greatly increase the social burden. Gestational diabetes mellitus (GDM) significantly increases the risk of diseases for pregnant women and infants, such as abortion and premature delivery, concurrent hypertension, concurrent infection, metabolic disorders, postpartum diabetes, macrosomia, fetal malformation, neonatal hypoglycemia, neonatal respiratory distress syndrome, and so on. It is one of the important public health problems threatening human health. Therefore, the accurate diagnosis of GDM is of great clinical significance for the timely formulation of intervention and treatment measures, reducing the risk of maternal and infant diseases and improving the level of public health.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus; Metabolomics Detection; Biomarker in Early Diagnosis
• Intervention / Treatment: Other: OGTT test

Detailed Description

The study will follow a prospective cohort design and be conducted in Peking Union Medical College Hospital. All basic information was collected in the first trimester, and all subjects underwent OGTT (75g glucose) at 24-28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG. At four time points during pregnancy (6-13 weeks, 24-28 weeks, 36-weeks before delivery, and 6 weeks after delivery), blood samples of 5ml were collected from each subject at each time point without increasing the number of blood samples. In the GDM group, blood samples were collected at the same time during routine visit 6 weeks after delivery. The relevant broad metabolomics and targeted vitamin profiles were also detected. Meanwhile, blood glucose values at the corresponding time points were collected. Using these variables, we will combine the metabolomics information to screen a predictive marker for GDM in Chinese reproductive age population.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Chinese Academy of Medical Science & Peking Union Medical College Hospital
      • Contact: Sun Yin, MD; Phone Number: 13901014196; Email: sunyin@pumch.cn
      • Contact: Wang Yaxin; Phone Number: 16601119185; Email: wangyaxin0205@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnancies with gestational diabetes mellitus and no gestational diabetes

Description

Inclusion Criteria:

• First trimester (6-13 weeks)；Pregnant women with a singleton pregnancy；Pregnant women who are registered at the hospital and have regular antenatal check-ups；Pregnant women who volunteered for the study were required to sign an informed consent form

Exclusion Criteria:

• Pregnant women with known type 1 or type 2 diabetes mellitus；Pregnant women with hyperlipidemia and hyperbilirubinemia；Pregnant women with hepatic and renal insufficiency

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with GDM; All basic information was collected in the first trimester, and all subjects underwent OGTT (75g glucose) at 24-28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG. At four time points during pregnancy (6-13 weeks, 24-28 weeks, 36-weeks before delivery, and 6 weeks after delivery), blood samples of 5ml were collected from each subject at each time point without increasing the number of blood samples. In the GDM group, blood samples were collected at the same time during routine visit 6 weeks after delivery. The relevant broad metabolomics and targeted vitamin profiles were also detected.	Other: OGTT test; The OGTT test (75g glucose) was performed between 24 and 28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG.
Women with no-GDM; All basic information was collected in the first trimester, and all subjects underwent OGTT (75g glucose) at 24-28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG. At three time points during pregnancy (6-13 weeks, 24-28 weeks, 36-weeks before delivery), blood samples of 5ml were collected from each subject at each time point without increasing the number of blood samples. The relevant broad metabolomics and targeted vitamin profiles were also detected.	Other: OGTT test; The OGTT test (75g glucose) was performed between 24 and 28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GDM（Pregnancies with gestational diabetes mellitus and no gestational diabetes）	For pregnant women without diabetes before pregnancy, 75g glucose tolerance test (OGTT) was performed at 24-28 weeks of pregnancy as a diagnostic test. The cutting value was that the blood glucose level reached or exceeded 5.1mmol/L, 10.0mmol/L and 8.5mmol/L 0、 1 and 2 hours after taking sugar, respectively. Using standard of the International Association of Diabetes and Pregnancy Study Group (IADPSG), GDM is diagnosed with blood glucose at any point or above the above values.	24-28weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: December 26, 2022
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: GDM; Metabolomics detection; Biomarker in Early Diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Disease; Diabetes, Gestational
• Other Study ID Numbers: JS-3582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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