Wenzhou Gestational Diabetes Cohort (WGDC)

March 30, 2025 updated by: Westlake University
The Wenzhou Gestational Diabetes Cohort (WGDC) is a prospective cohort study among women with gestational diabetes mellitus (GDM) during pregnancy and their offspring living in Wenzhou, 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 GDM over 2 weeks, and to facilitate the development of personalized nutritional/lifestyle recommendation among these patients. Another aim of the WGDC 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, macrosomia and large-for-gestational-age birth. The secondary aim is to investigate the prospective associations of diet, physical activity and continuous glucose change over 2 weeks among the patients with long-term metabolic health of the women and their offspring.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In China, an alarming increase in the prevalence of GDM has been observed in the past decade. GDM is of concern because it is 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. However, the associations between dietary intake and physical activity and health outcomes for GDM women and their children remain unclear due to subjective measurements of diet and physical activity. Recently, the development of objective measurements 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 women may have different blood glucose responses, but the nature of variation is currently poorly characterized. Therefore, the present WGDC design incorporates three unique components, 1) objective measurement of physical activity during pregnancy using accelerometer; 2) measurement of dietary intake using both Food Frequency Questionnaire and daily dietary records; 3) measurement of blood glucose levels over 2 weeks using continuous glucose monitors, with three standardized test meals during the 2 weeks. We will then follow up these women participants during and after this pregnancy, and also follow up their offspring.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

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 Locations

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Women with cancer and other serious medical disorders

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Standardized breakfast
Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g)
Other: Standardized breakfast
Participants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device.
Other: Standardized snack
Tomato (50g) and skim milk (200g)
Other: Standardized snack
Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast.
Other: Standardized lunch
Rice (40g), oats (40g), shrimp (70g), lettuce (80g), lean pork (30g), carrot (10g), soaked auricularia auricula (20g), broccoli (80g), cucumber (10g), tomato egg drop soup (200g), salt (3g), and oil (8g)
Other: Standardized lunch
Participants will be provided with a standardized lunch 2 h after they have the standardized snack.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse birth outcomes
Time Frame: 9-12 weeks after enrollment
Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.
9-12 weeks after enrollment
Continuous blood glucose change over 2 weeks
Time Frame: two weeks after enrollment
Glucose levels are assessed by continuous glucose monitoring over 2 weeks.
two weeks after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight changes during early childhood
Time Frame: at delivery, age of 6 months, 1 year, 3 years and 6 years
Weight in kilograms
at delivery, age of 6 months, 1 year, 3 years and 6 years
Number of participants developing type 2 diabetes
Time Frame: 6 years and 10 years after delivery
Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.
6 years and 10 years after delivery

Collaborators and Investigators

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

Sponsor

Westlake University

Collaborators

Wenzhou People's Hospital

Investigators

  • Principal Investigator: Ju-Sheng Zheng, PhD, Westlake University

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)

March 21, 2023

Primary Completion (Estimated)

March 21, 2026

Study Completion (Estimated)

March 21, 2033

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 30, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20221213ZJS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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