Wenzhou Zwangerschapsdiabetescohort (WGDC)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Zhejiang
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Wenzhou, Zhejiang, China, 325000
- Wenzhou People's Hospital
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: Standardized breakfast
Egg (50g), whole-wheat bread (35g), celery (30g), and dried bean curd (10g) |
Participants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device. |
|
Ander: Standardized snack
Tomato (50g) and skim milk (200g) |
Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast. |
|
Ander: Standardized lunch
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) |
Participants will be provided with a standardized lunch 2 h after they have the standardized snack. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adverse birth outcomes
Tijdsspanne: 9-12 weeks after enrollment
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Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia. |
9-12 weeks after enrollment
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Continuous blood glucose change over 2 weeks
Tijdsspanne: two weeks after enrollment
|
Glucose levels are assessed by continuous glucose monitoring over 2 weeks. |
two weeks after enrollment
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of participants developing type 2 diabetes
Tijdsspanne: 6 years and 10 years after delivery
|
Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes. |
6 years and 10 years after delivery
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Weight changes during early childhood
Tijdsspanne: at delivery, age of 6 months, 1 year, 3 years and 6 years
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Weight in kilograms |
at delivery, age of 6 months, 1 year, 3 years and 6 years
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ju-Sheng Zheng, PhD, Westlake University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20221213ZJS001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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