- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04550806
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
Conditions
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
- Name: Kang Yu, MD
- Phone Number: +8613801130457
- Email: yuk1997@sina.com
Study Contact Backup
- Name: Fang Wang, MD
- Phone Number: +8615201646084
- Email: yours.fang@Hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Kang Yu, MD, PHD
- Phone Number: +8613801130457
- Email: yuk1997@sina.com
-
Contact:
- Fang Wang, MD, MS
- Phone Number: +8615201646084
- Email: yours.fang@hotmail.com
-
-
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZS-1703
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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