Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Prediction

October 16, 2020 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Unknown

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

pregnant women at first trimester

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
GDM
non-GDM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlative factors for GDM
Time Frame: May 2021
regression model to detect correlative factors for GDM
May 2021
GDM prediction model establishment
Time Frame: May 2021
multiple regression model to establish screening system for GDM
May 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Kang Yu, MD, Clinical nutrition department of Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 16, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

we can update the information collected of this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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