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

Gestational Diabetes Clinical Trial

Official title:

To Identify Urinary Biomarkers in the First Trimester Associated With Gestational Diabetes Mellitus [GDM] and Achieve Early Diagnosis of GDM Using Urinary Proteomic Analysis: An Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992974
• Other study ID #: 202303075GDM
• Secondary ID: K4087
• Status: Recruiting
• Start date: August 31, 2023
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Peking Union Medical College Hospital
• Contact: Yanbei Duo, Dr.
• Phone: 86+15561852093
• Email: duoduo15561852093[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
China	Mudanjiang First People's Hospital	Mudanjiang	Heilongjiang
China	Mudanjiang Maternal and Child Health Hospital	Mudanjiang	Heilongjiang

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Mudanjiang First People's Hospital, Mudanjiang Maternal and Child Health Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

Duo Y, Song S, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. Predictability of HOMA-IR for Gestational Diabetes Mellitus in Early Pregnancy Based on Different First Trimester BMI V — View Citation

Song S, Duo Y, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. The Predictive Ability of Hepatic Steatosis Index for Gestational Diabetes Mellitus and Large for Gestational Age Infan — View Citation

Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Lu Z, Liu S, Zhao T, Yuan T, Fu Y, Dong Y, Zhao W, Sun W, Wang A. HOMA-IR as a risk factor of gestational diabetes mellitus and a novel simple surrogate index in early pr — View Citation

Song S, Zhang Y, Qiao X, Duo Y, Xu J, Peng Z, Zhang J, Chen Y, Nie X, Sun Q, Yang X, Wang A, Lu Z, Sun W, Fu Y, Dong Y, Yuan T, Zhao W. ALT/AST as an Independent Risk Factor of Gestational Diabetes Mellitus Compared with TG/HDL-C. Int J Gen Med. 2022 Jan — View Citation

Wang X, Zhao M, Guo Z, Song S, Liu S, Yuan T, Fu Y, Dong Y, Sun H, Liu X, Zhou D, Zhao W, Sun W. Urinary proteomic analysis during pregnancy and its potential application in early prediction of gestational diabetes mellitus and spontaneous abortion. Ann T — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with gestational diabetes	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	at 24-28 weeks of gestation