Clinical trial NCT05794152: Wenzhou Gestational Diabetes Cohort
Official title: Wenzhou Gestational Diabetes Cohort
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus
Intrauterine Hyperglycemia
Birth Outcome, Adverse
Nutrition, Healthy
Keywords: Precision Nutrition
Host and Microbiome
Birth Outcomes
Lead sponsor: Westlake University
Sponsor class: OTHER
Collaborators: name: Wenzhou People's Hospital
First posted: 2023-04-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Continuous blood glucose change over 2 weeks
timeFrame: two weeks after enrollment
measure: Adverse birth outcomes
timeFrame: 9-12 weeks after enrollment
Secondary outcomes:
measure: Weight changes during early childhood
timeFrame: at delivery, age of 6 months, 1 year, 3 years and 6 years
measure: Number of participants developing type 2 diabetes
timeFrame: 6 years and 10 years after delivery
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou People's Hospital
state: Zhejiang
Study officials:
affiliation: Westlake University
name: Ju-Sheng Zheng, PhD
role: PRINCIPAL_INVESTIGATOR
References: