Wenzhou Gestational Diabetes Cohort

Not Applicable

Recruiting

• Conditions: Intrauterine Hyperglycemia; Birth Outcome, Adverse; Nutrition, Healthy; Gestational Diabetes Mellitus
• Interventions: Other: Standardized breakfast; Other: Standardized lunch; Other: Standardized snack

• Registration Number: NCT05794152
• Lead Sponsor: Westlake University

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.

Study Timeline

• Study First Submitted: 2023-02-13
• Study Start: 2023-03-21
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-03-21
• Study Completion: 2033-03-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standardized breakfast	Standardized breakfast	Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g)
Standardized lunch	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)
Standardized snack	Standardized snack	Tomato (50g) and skim milk (200g)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wenzhou People's Hospital; 🇨🇳 Wenzhou, Zhejiang, China