Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05794152

Wenzhou Gestational Diabetes Cohort

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standardized breakfast

Other

Participants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device.

Standardized snack

Other

Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast.

Standardized lunch

Other

Participants will be provided with a standardized lunch 2 h after they have the standardized snack.

Primary outcomes

  1. Continuous blood glucose change over 2 weeks

    Time frame: two weeks after enrollment

    Glucose levels are assessed by continuous glucose monitoring over 2 weeks.

  2. 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.

Secondary outcomes

  1. Weight changes during early childhood

    Time frame: at delivery, age of 6 months, 1 year, 3 years and 6 years

    Weight in kilograms

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ju-Sheng Zheng, PhD

CONTACT

[email protected]

86-0571-86915303

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Collaborators

  • Wenzhou People's Hospital

Registry information

Acronym: WGDC

Important dates

Study start
2023
Primary completion
2026
Study completion
2033
First posted
Apr 3, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.