Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Prediction

NCT ID: NCT04550806

Last Updated: 2020-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-07-01

Brief Summary

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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

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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.

Conditions

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Gestational Diabetes Mellitus in Pregnancy

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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GDM

No interventions assigned to this group

non-GDM

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kang Yu, MD

Role: STUDY_DIRECTOR

Clinical nutrition department of Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kang Yu, MD

Role: CONTACT

+8613801130457

Fang Wang, MD

Role: CONTACT

+8615201646084

Facility Contacts

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Kang Yu, MD, PHD

Role: primary

+8613801130457

Fang Wang, MD, MS

Role: backup

+8615201646084

Other Identifiers

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ZS-1703

Identifier Type: -

Identifier Source: org_study_id

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