Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Prediction

• Conditions: Gestational Diabetes Mellitus in Pregnancy

• Registration Number: NCT04550806
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-16
• Status Verified: 2020-10
• Study Start: 2020-10-01
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-20
• Primary Completion: 2021-06-01
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the curve of GA combined with body composition for GDM diagnosis	May 2021	prediction ability of GA and body compostion

Secondary Outcome Measures

Name	Time	Method
correlative factors for GDM	May 2021	regression model to detect correlative factors for GDM
GDM prediction model establishment	May 2021	multiple regression model to establish screening system for GDM

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China