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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03246295
Other study ID # ZS976
Secondary ID
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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