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Wenzhou Gestational Diabetes Cohort

ConditionsGestational Diabetes MellitusIntrauterine HyperglycemiaBirth Outcome, AdverseNutrition, Healthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWestlake University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Women with cancer and other serious medical disorders

Trial design

Design model

Single group

Treatments tested in this trial

  • Standardized breakfast

    Other intervention

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

  • Standardized snack

    Other intervention

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

  • Standardized lunch

    Other intervention

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

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Standardized breakfastOther 1 intervention
Group B: Standardized snackOther 1 intervention
Group C: Standardized lunchOther 1 intervention

Trial outcomes

Primary outcomes

1

Continuous blood glucose change over 2 weeks

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

Time frame
two weeks after enrollment
2

Adverse birth outcomes

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

Time frame
9-12 weeks after enrollment

Secondary outcomes

1

Weight changes during early childhood

Weight in kilograms

Time frame
at delivery, age of 6 months, 1 year, 3 years and 6 years
2

Number of participants developing type 2 diabetes

Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.

Time frame
6 years and 10 years after delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Westlake University

Lead sponsor

Wenzhou People's Hospital

Collaborator

Source ClinicalTrials.gov
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