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临床试验/NCT05794152
NCT05794152招募中不适用

Wenzhou Gestational Diabetes Cohort

Westlake University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Adverse birth outcomes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Women with cancer and other serious medical disorders

结局指标

主要结局

Adverse birth outcomes

时间窗: 9-12 weeks after enrollment

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

Continuous blood glucose change over 2 weeks

时间窗: two weeks after enrollment

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

次要结局

  • Weight changes during early childhood(at delivery, age of 6 months, 1 year, 3 years and 6 years)
  • Number of participants developing type 2 diabetes(6 years and 10 years after delivery)

研究者

发起方
Westlake University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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