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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05992974

Enrollment

1000

Registered

2023-08-15

Start date

2023-08-31

Completion date

2025-12-31

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

gestational diabetes, urinary proteomics, early prediction

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactYanbei Duo, Dr.

duoduo15561852093@163.com86+15561852093

Outcome results