Wenzhou Gestational Diabetes Cohort

NCT05794152 | Recruiting DMC

• 1 other identifier: 20221213ZJS001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Precision Nutrition; Host and Microbiome; Birth Outcomes

Outcome Measures

Primary Outcomes (2)

• Continuous blood glucose change over 2 weeks

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

  two weeks after enrollment

• Adverse birth outcomes

  Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.

  9-12 weeks after enrollment

Secondary Outcomes (2)

• Weight changes during early childhood

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

• Number of participants developing type 2 diabetes

  6 years and 10 years after delivery

Study Arms (3)

Standardized breakfast

OTHER

Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g)

Other: Standardized breakfast

Standardized snack

OTHER

Tomato (50g) and skim milk (200g)

Other: Standardized snack

Standardized lunch

OTHER

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

Interventions

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 breakfast

Standardized snack OTHER

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

Standardized snack

Standardized lunch OTHER

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

Standardized lunch

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women with cancer and other serious medical disorders

Sponsors & Collaborators

• Westlake University: lead
• Wenzhou People's Hospital: collaborator

Study Sites (1)

Wenzhou People's Hospital

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ju-Sheng Zheng, PhD

  Westlake University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ju-Sheng Zheng, PhD

CONTACT

86-0571-86915303; zhengjusheng@westlake.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: April 3, 2023
• Study Start: March 21, 2023
• Primary Completion: March 21, 2026
• Study Completion (Estimated): March 21, 2033
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

CN (1)