Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Prediction

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04550806
• Other study ID #: ZS-1703
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: October 2020
• Source: Peking Union Medical College Hospital
• Contact: Kang Yu, MD
• Phone: +8613801130457
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of GA combined with body composition for GDM diagnosis	prediction ability of GA and body compostion	May 2021
Secondary	correlative factors for GDM	regression model to detect correlative factors for GDM	May 2021
Secondary	GDM prediction model establishment	multiple regression model to establish screening system for GDM	May 2021