To Identify Urinary Biomarkers Associated With Gestational Diabetes Mellitus [GDM]

Recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT05992974
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Gestational diabetes mellitus(GDM) is one of the most common complications of pregnancy. The incidence of GDM is higher in Asian than in other regions, and GDM can increase the risk of a series of perinatal complications. The investigators has been committed to the early diagnosis of GDM, and several biomarkers in the first trimester and urinary proteomic markers that were associated with GDM have been found. Based on the previous work, the aim of this study was to verify the predictive ability of urinary proteomic markers for GDM that has been found in the previous study of the researchers. This study is a multi-center, prospective, and observational study. Urine samples will be collected twice, at 12 weeks and 24-28 weeks of gestation, respectively.

Detailed Description

The eligibility criteria are as follows:

1. singleton pregnant women over 18 years old;

2. gestational age less than 12 weeks;

3. regular follow-up until delivery;

4. able to understand and sign an informed consent.

The exclusion criteria of pregnant women are as follows:

1. with impaired glucose tolerance or diabetes mellitus before pregnancy;

2. severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy);

3. medications other than vitamins used during pregnancy;

4. inability to understand and follow-up regularly;

5. other conditions judged by the investigators to be inappropriate for participation in the study.

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-07
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Study Start: 2023-08-31
• Last Update Submitted: 2023-09-30
• Last Update Posted: 2023-10-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Women of childbearing age who are in early pregnancy(gestational age less than 12 weeks);
• Regular prenatal examination until delivery;
• Older than 18 years old;
• Obtained informed consent from participants and/or their family members.

Exclusion Criteria

• Twins or multiple pregnancy;
• With impaired glucose tolerance or diabetes mellitus before pregnancy;
• With severe chronic diseases or infectious diseases (e.g., liver disease, urinary system disease, cardiovascular disease, autoimmune disease, hematological disease, AIDS and other diseases before pregnancy);
• Medications other than vitamins used during pregnancy;
• Inability to understand and follow-up regularly;
• Other conditions that were judged by the investigator to be ineligible for participation in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with gestational diabetes	at 24-28 weeks of gestation	Diagnosed by 75g-OGTT at 24-28 weeks of gestation. GDM was diagnosed according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criterion in 2010: fasting blood glucose ≥5.1mmol/L, and/or 1-hour blood glucose ≥10.0mmol/L, and/or 2-hour blood glucose ≥8.5mmol/L

Trial Locations

Locations (2)

Mudanjiang Maternal and Child Health Hospital; 🇨🇳 Mudanjiang, Heilongjiang, China

Mudanjiang First People's Hospital; 🇨🇳 Mudanjiang, Heilongjiang, China