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Wenzhou svangerskabsdiabetes kohorte (WGDC)

24. september 2026 opdateret af: Westlake University

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Zhejiang
      • Wenzhou, Zhejiang, Kina, 325000
        • Wenzhou People's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.

Andet: Standardized snack

Tomato (50g) and skim milk (200g)

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

Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse birth outcomes
Tidsramme: 9-12 weeks after enrollment

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

9-12 weeks after enrollment
Continuous blood glucose change over 2 weeks
Tidsramme: two weeks after enrollment

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

two weeks after enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants developing type 2 diabetes
Tidsramme: 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
Weight changes during early childhood
Tidsramme: at delivery, age of 6 months, 1 year, 3 years and 6 years

Weight in kilograms

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Ju-Sheng Zheng, PhD, Westlake University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. marts 2023

Primær færdiggørelse (Faktiske)

1. november 2025

Studieafslutning (Anslået)

21. marts 2035

Datoer for studieregistrering

Først indsendt

13. februar 2023

Først indsendt, der opfyldte QC-kriterier

29. marts 2023

Først opslået (Faktiske)

3. april 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2026

Sidst verificeret

1. august 2026

Mere information

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