Wenzhou People's Hospital
Wenzhou, Zhejiang, 325000, China
Location status: Recruiting
Location contact
Ju-Sheng Zheng, PhD
CONTACT
Ju-Sheng Zheng, PhD
PRINCIPAL_INVESTIGATOR
Xinxiu Liang
CONTACT
NCT Number: NCT05794152
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Wenzhou, Zhejiang, 325000, China
Location status: Recruiting
Ju-Sheng Zheng, PhD
CONTACT
Ju-Sheng Zheng, PhD
PRINCIPAL_INVESTIGATOR
Xinxiu Liang
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be provided with a standardized breakfast on a morning of the days they wear a continuous glucose monitoring (CGM) device.
Participants will be provided with a standardized snack 2 hour after they have the standardized breakfast.
Participants will be provided with a standardized lunch 2 h after they have the standardized snack.
Time frame: two weeks after enrollment
Glucose levels are assessed by continuous glucose monitoring over 2 weeks.
Time frame: 9-12 weeks after enrollment
Number of participants with adverse birth outcomes, such as, preterm birth, macrosomia and neonatal hypoglycemia.
Time frame: at delivery, age of 6 months, 1 year, 3 years and 6 years
Weight in kilograms
Time frame: 6 years and 10 years after delivery
Risk of developing type 2 diabetes after the delivery of the women with gestational diabetes.
Contact information is provided by the study sponsor or research team.
Westlake University
Other
Acronym: WGDC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04621396
Diabetes Mellitus, Diabetes Mellitus, Type 2
Winnipeg, Manitoba, Canada
View Trial DetailsNCT07158970
Diabetes Mellitus, Diabetes, Gestational
H̱olon, Central District, Israel
View Trial DetailsNCT06445946
Diabetes Mellitus, Diabetes, Gestational
Tuscaloosa, Alabama, United States
View Trial DetailsNCT06436326
Continuous Glucose Monitoring, Diabetes Mellitus
Hsinchu, Taiwan
View Trial Details