Skip to content

Wenzhou Gestational Diabetes Cohort

Wenzhou Gestational Diabetes Cohort

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05794152
Acronym
WGDC
Enrollment
300
Registered
2023-04-03
Start date
2023-03-21
Completion date
2033-03-21
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus, Intrauterine Hyperglycemia, Birth Outcome, Adverse, Nutrition, Healthy

Keywords

Precision Nutrition, Host and Microbiome, Birth Outcomes

Brief summary

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.

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.

Interventions

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

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

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

Sponsors

Wenzhou People's Hospital
CollaboratorOTHER
Westlake University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Continuous blood glucose change over 2 weekstwo weeks after enrollmentGlucose levels are assessed by continuous glucose monitoring over 2 weeks.
Adverse birth outcomes9-12 weeks after enrollmentNumber of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.

Secondary

MeasureTime frameDescription
Weight changes during early childhoodat delivery, age of 6 months, 1 year, 3 years and 6 yearsWeight in kilograms
Number of participants developing type 2 diabetes6 years and 10 years after deliveryRisk of developing type 2 diabetes after the delivery of the women with gestational diabetes.

Countries

China

Contacts

Primary ContactJu-Sheng Zheng, PhD
zhengjusheng@westlake.edu.cn86-0571-86915303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026