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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yanbei Duo, Dr.; Phone Number: 86+15561852093; Email: duoduo15561852093@163.com

Study Locations

• China
  • Heilongjiang
    • Mudanjiang, Heilongjiang, China
      • Recruiting
      • Mudanjiang First People's Hospital
      • Contact: Yanbei Duo, Dr.; Phone Number: 86+15561852093
    • Mudanjiang, Heilongjiang, China
      • Recruiting
      • Mudanjiang Maternal and Child Health Hospital
      • Contact: Yanbei Duo; Phone Number: 86+15561852093; Email: duoduo15561852093@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Our study population was pregnant women in early pregnancy who regularly visited the following two medical center: Mudanjiang First People's Hospital, and Mudanjiang Maternal and Child Health Care Hospital. All pregnant women within 12 gestational weeks are eligible for enrollment, and whether entry or not depends on their own preference. There were no requirements for household registration, place of residence, and other identify informations of the enrolled women.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Mudanjiang First People's Hospital; Mudanjiang Maternal and Child Health Hospital
• Investigators: Principal Investigator: Tedros Adhanom Ghebreyesus, World Health Organization

Publications and helpful links

General Publications

• 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 Transl Med. 2022 Jul;10(13):736. doi: 10.21037/atm-21-3497.
• 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 Infant Compared with Other Noninvasive Indices Among Chinese Pregnancies: A Preliminary Double-center Cohort Study. Diabetes Metab Syndr Obes. 2021 Dec 16;14:4791-4800. doi: 10.2147/DMSO.S335364. eCollection 2021.
• 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 pregnancy. Int J Gynaecol Obstet. 2022 Jun;157(3):694-701. doi: 10.1002/ijgo.13905. Epub 2021 Sep 24.
• 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 Values. J Pers Med. 2022 Dec 28;13(1):60. doi: 10.3390/jpm13010060.
• 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 5;15:115-121. doi: 10.2147/IJGM.S332946. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: gestational diabetes; early prediction; urinary proteomics
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 202303075GDM; K4087 (Other Grant/Funding Number: Peking Union Medical College Hospital)

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