Wenzhou Gestational Diabetes Cohort

Gestational Diabetes Mellitus Clinical Trial

— WGDC  

Official title:

Wenzhou Gestational Diabetes Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794152
• Other study ID #: 20221213ZJS001
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: March 21, 2033

Study information

• Verified date: February 2023
• Source: Westlake University
• Contact: Ju-Sheng Zheng, PhD
• Phone: 86-0571-86915303
• Email: zhengjusheng[@]westlake.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 21, 2033
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Hyperglycemia
• Intrauterine Hyperglycemia
• Pregnancy Complications

Intervention

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

Locations

Country	Name	City	State
China	Wenzhou People's Hospital	Wenzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Westlake University	Wenzhou People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous blood glucose change over 2 weeks	Glucose levels are assessed by continuous glucose monitoring over 2 weeks.	two weeks after enrollment
Primary	Adverse birth outcomes	Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.	9-12 weeks after enrollment
Secondary	Weight changes during early childhood	Weight in kilograms	at delivery, age of 6 months, 1 year, 3 years and 6 years
Secondary	Number of participants developing type 2 diabetes	Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.	6 years and 10 years after delivery