Gestational Diabetes MellitusWGDCNCT05794152
Wenzhou Gestational Diabetes Cohort
A study testing Standardized breakfast, Standardized snack and Standardized lunch in people with Gestational Diabetes Mellitus and Intrauterine Hyperglycemia, run by Westlake University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus, Intrauterine Hyperglycemia, Birth Outcome, Adverse
- What is being tested?
- Standardized breakfast, Standardized snack and Standardized lunch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to 21 Mar 2035
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women with cancer and other serious medical disorders
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus, Intrauterine Hyperglycemia, Birth Outcome, Adverse, Nutrition, Healthy
- Being tested
- Standardized breakfast, Standardized snack, Standardized lunch
- Keywords
- Precision Nutrition, Host and Microbiome, Birth Outcomes
- Medical subject headings
- Diabetes, Gestational, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized breakfastOther
Participants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device.
Standardized snackOther
Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast.
Standardized lunchOther
Participants will be provided with a standardized lunch 2 h after they have the standardized snack.
| Study group | Role | What they receive |
|---|---|---|
| Standardized breakfast | Other | Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g) Receives: Other: Standardized breakfast |
| Standardized snack | Other | Tomato (50g) and skim milk (200g) Receives: 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) Receives: Other: Standardized lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous blood glucose change over 2 weeks
Glucose levels are assessed by continuous glucose monitoring over 2 weeks.
Measured: two weeks after enrollment
Adverse birth outcomes
Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.
Measured: 9-12 weeks after enrollment
Secondary outcomes (2)
Weight changes during early childhood
Weight in kilograms
Measured: at delivery, age of 6 months, 1 year, 3 years and 6 years
Number of participants developing type 2 diabetes
Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.
Measured: 6 years and 10 years after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start21 Mar 2023
- Primary completion1 Nov 2025
- Study completion21 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou People's Hospital
- Responsible party
- Sponsor
- Investigators
- Ju-Sheng Zheng, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794152
- Sponsor's protocol ID
- 20221213ZJS001
- Acronym
- WGDC
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided