- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05794152
Wenzhou svangerskapsdiabetes kohort (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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Zhejiang
-
Wenzhou, Zhejiang, Kina, 325000
- Wenzhou People's Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: 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. |
|
Annen: Standardized snack
Tomato (50g) and skim milk (200g) |
Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast. |
|
Annen: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ju-Sheng Zheng, PhD, Westlake University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20221213ZJS001
Plan for individuelle deltakerdata (IPD)
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