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Clinical Trials/NCT04550806
NCT04550806
Unknown
Not Applicable

The Predictive Ability of Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Diagnosis

Peking Union Medical College Hospital1 site in 1 country300 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes Mellitus in Pregnancy
Sponsor
Peking Union Medical College Hospital
Enrollment
300
Locations
1
Primary Endpoint
Area under the curve of GA combined with body composition for GDM diagnosis
Last Updated
5 years ago

Overview

Brief Summary

This study is going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis.

Detailed Description

The prevalence of GDM is increasing all over the world. It has bad influence for both pregnant women and fetus. Early treatment is useful for GDM prevention. Therefore early screening is important for healthcare doctors to detect the potential patients. Glycated albumin (GA) is an optimal index for blood glucose evaluation compared to HbA1c, however it may be influenced by body weight and composition. The investigators are going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis. This study recruit pregnant women before 12 weeks of their pregnant age and test GA level and body composition via bioelectrical impedance analysis. During 24-28 weeks of pregnant age, all participants will do the glucose tolerant test for GDM diagnosis.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
July 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age between 20-45
  • Healthy, without heart disease, liver or kidney dysfunction, immune system or metabolic or infectious disease,

Exclusion Criteria

  • Diabetes that appeared before pregnancy
  • Pregnant with medical disease, such as asthma, hypertension, cardiovascular diseases, kidney diseases or liver disease.
  • Hormone use in the recent 1 year
  • Assisted reproduction pregnancy
  • Multiple births
  • Cannot complete the blood test or body composition examination

Outcomes

Primary Outcomes

Area under the curve of GA combined with body composition for GDM diagnosis

Time Frame: May 2021

prediction ability of GA and body compostion

Secondary Outcomes

  • correlative factors for GDM(May 2021)
  • GDM prediction model establishment(May 2021)

Study Sites (1)

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