Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis

Gestational Diabetes Mellitus Clinical Trial

Official title:

Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03246295
• Other study ID #: ZS976
• Status: Active, not recruiting
• Phase: N/A
• First received: July 23, 2017
• Last updated: August 7, 2017
• Start date: October 20, 2015
• Est. completion date: October 1, 2017

Study information

• Verified date: August 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses. At present, no prediction marker for GDM in early pregnancy is accepted. There is still a lack of recognized early predictors. This study was designed to identity valuable biomarkers for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed according to the latest ADA standard. Urinary samples were collected in the first (<12 weeks), second (24~28 weeks) and third (32~weeks) trimester of pregnancy. Urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal analysis; 15 cases of GDM women and 15 cases of age matched control women were used for difference analysis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: October 1, 2017
• Est. primary completion date: September 1, 2017
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

-Pregnant women (<12 weeks)

Exclusion Criteria:

• with renal dysfunction

• urine routine examination abnormalities for twice

• history of urinary and reproductive system diseases

• with other chronic diseases

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Other:
• lifestyle intervention or insulin treatment
Firstly,the gestational diabetes mellitus(GDM) women were treated with lifestyle intervention.Those women were treated with insulin if their blood glucose was not well Controled.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary samples were analyzed	Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.	in the first (<12 weeks) trimester of pregnancy
Secondary	Urinary samples were analyzed	Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.	in the second (24-28 weeks) trimester of pregnancy
Secondary	Urinary samples were analyzed	Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.	in the third (>32 weeks) trimester of pregnancy