Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04060056
Previous Study | Return to List | Next Study

Westlake Precision Birth Cohort (WEBIRTH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04060056
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Hangzhou Women's Hospital, China
Information provided by (Responsible Party):
Westlake University

Brief Summary:
The WEstlake precision BIRTH cohort(WEBIRTH) is a prospective cohort study among women with hyperglycemia during pregnancy and their offspring living in Hangzhou, China. The primary aim of this cohort is to characterize the continuous blood glucose response to dietary intake and physical activity among pregnant women with hyperglycemia over 2 weeks, and to facilitate the development of personalized nutritional/lifestyle recommendation among these patients. Another aim of WEBIRTH is to investigate the association of dietary and physical activity together with continuous glucose change during pregnancy on the adverse birth outcomes including preterm birth, low birth weight and small-for-gestational age birth. The secondary aim is to investigate the prospective associations of diet, physical activity and continuous glucose change over 2 week among the patients with the long-term metabolic health of the women and their offspring.

Condition or disease
Diabetes, Gestational Pregnancy in Diabetics Intrauterine Hyperglycemia

Detailed Description:
In China, an alarming increase in the prevalence of gestational diabetes mellitus (GDM)/ diabetes in pregnancy (DIP) patients has been observed in the past decade. GDM and DIP are of concern because they are associated with several maternal and fetal medical disorders. Lifestyle changes such as diet and physical activity modifications are key for the prevention and treatment of GDM/DIP. However, the associations between dietary intake and physical activity and health outcomes for GDM/DIP women and their children remain unclear due to subjective measurements of diet and physical activity. Recently, the development of objective measurement such as food image identification and wearable activity trackers give an opportunity to gain more precise insight into these associations. In addition, for the same food and physical activity exposure, GDM/DIP women may have different blood glucose responses, but the nature of variation is currently poorly characterized. Therefore, the present WEBIRTH design incorporates three unique components, 1) objective measurement of physical activity during pregnancy using accelerometer; 2) measurement of dietary intake using both FFQ and food photos; 3) measurement of blood glucose levels over 2 weeks using continuous glucose monitors, with a standardized test meal during the 2 weeks. We will then follow up these women participants during and after this pregnancy, and also follow up their offspring.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Westlake Precision Birth Cohort
Actual Study Start Date : August 30, 2019
Estimated Primary Completion Date : July 11, 2022
Estimated Study Completion Date : July 11, 2029



Primary Outcome Measures :
  1. Continuous blood glucose change over 2 weeks [ Time Frame: two weeks after enrollment ]
    Glucose levels are assessed by continuous glucose monitoring over 2 week

  2. Adverse birth outcomes [ Time Frame: 9-12 weeks after enrollment ]
    Risk of preterm birth, low birth weight and small-for-gestational age


Secondary Outcome Measures :
  1. Body composition after delivery [ Time Frame: 6 months and 3 years after delivery ]
    Body composition (fat mass, lean mass in kg ) are assessed by DXA for both mothers and infants

  2. Weight changes during early childhood [ Time Frame: at delivery, age of 6 months, 1 year, 3 years and 6 years ]
    Weight in kilograms

  3. type 2 diabetes [ Time Frame: 6 years and 10 years after delivery ]
    Risk of developing type 2 diabetes after the delivery of their children among these women with pregnancy hyperglycemia


Biospecimen Retention:   Samples With DNA
During pregnancy: maternal blood, urine, saliva and stool. At delivery: cord blood and placenta. During infancy: stool and urine. During childhood: blood, saliva, urine and stool.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are diagnosed with GDM or DIP at 24-32 weeks of gestation will be recruited at the Hangzhou Women's Hospital, China.
Criteria

Inclusion Criteria:

  • Women aged 18 yrs or older
  • Women with GDM or DIP at 24-28 weeks of gestation
  • Women intended to deliver at Hangzhou Women's Hospital
  • Women intended to remain in Hangzhou with their child for ≥4 years

Exclusion Criteria:

● Women with cancer and other serious medical disorders


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04060056


Contacts
Layout table for location contacts
Contact: Ju-Sheng Zheng, PhD 86-0571-86915303 zhengjusheng@westlake.edu.cn

Locations
Layout table for location information
China, Zhejiang
Hangzhou Women's Hospital Recruiting
Hangzhou, Zhejiang, China, 310008
Contact: Ju-Sheng Zheng, PhD    86-0571-86915303    zhengjusheng@westlake.edu.cn   
Contact: Zelei Miao    86-0571-86915303    miaozelei@westlake.edu.cn   
Sponsors and Collaborators
Westlake University
Hangzhou Women's Hospital, China
Investigators
Layout table for investigator information
Principal Investigator: Ju-Sheng Zheng, PhD Westlake University
Layout table for additonal information
Responsible Party: Westlake University
ClinicalTrials.gov Identifier: NCT04060056    
Other Study ID Numbers: 20190701ZJS0007
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Westlake University:
Precision Nutrition
Host and Microbiome
Birth Outcomes
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Pregnancy in Diabetics
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications
Diabetes Mellitus
Endocrine System Diseases