Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Prediction

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04550806

Enrollment

300

Registered

2020-09-16

Start date

2020-10-01

Completion date

2021-07-01

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus in Pregnancy

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

22 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactKang Yu, MD

yuk1997@sina.com+8613801130457

Backup ContactFang Wang, MD

yours.fang@hotmail.com+8615201646084

Outcome results