NCT04550806

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

8 months

First QC Date

September 9, 2020

Last Update Submit

October 16, 2020

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Area under the curve of GA combined with body composition for GDM diagnosis

    prediction ability of GA and body compostion

    May 2021

Secondary Outcomes (2)

  • correlative factors for GDM

    May 2021

  • GDM prediction model establishment

    May 2021

Study Arms (2)

GDM

non-GDM

Eligibility Criteria

Age22 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women at first trimester

You may qualify if:

  • Age between 20-45
  • Healthy, without heart disease, liver or kidney dysfunction, immune system or metabolic or infectious disease,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Study Officials

  • Kang Yu, MD

    Clinical nutrition department of Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Kang Yu, MD

CONTACT

+8613801130457yuk1997@sina.com

Fang Wang, MD

CONTACT

+8615201646084yours.fang@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 16, 2020

Study Start

October 1, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

CN(1)