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临床试验/NCT06215352
NCT06215352招募中不适用

Influence of Chrono-nutrition Factors, Temporal Dietary Patterns, and Their Interactions With Dietary Quality During Pregnancy on Maternal Gestational Diabetes, Glycemic Parameters, and Gestational Weight Gain.

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2024年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
316
试验地点
1
主要终点
Gestational weight gain

研究概览

简要总结

This study aims to establish a new cohort study to investigate the relationship between chrono-nutrition factors during pregnancy and maternal GDM (Gestational diabetes mellitus), glycemic parameters, and gestational weight gain.

详细描述

Gestational diabetes mellitus (GDM), characterized by hyperglycemia first diagnosed during pregnancy, is associated with an increased risk of full-fledged type 2 diabetes (T2D) in mothers and adverse metabolic health in their offspring. In Taiwan, the prevalence of GDM has risen from 7.6% in 2004 to 13.4% in 2015, affecting approximately 1 in 7 pregnancies. Even at levels below the diagnostic threshold for GDM, studies such as the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) have shown a clear graded relationship between higher maternal glycemia and an elevated risk of adverse birth outcomes and childhood insulin resistance.

Metabolic health and glycemic profile of mothers are in turn heavily influenced by diet and nutrition. While dietary content is crucial, multiple lines of evidence now suggests that not only what one eats but also when one eats impacts health. The master circadian clock in the human brain orchestrates circadian rhythms in response to the light-dark cycle. However, it is now recognized that most organs possess peripheral circadian clocks that are strongly influenced by behavioral rhythms, including feeding/fasting, activity/rest, and wake/sleep cycles. Chrono-nutrition is an emerging field of study concerning the interplay between the endogenous circadian rhythm, dietary intake, metabolism, and health. There are various dimensions of chrono-nutrition including meal timing, frequency, and regularity, and daily fasting duration. These individual dimensions have been linked to health outcomes, but few studies have examined the intricate interconnectedness across these different dimensions. Another research gap is that there is a dearth of studies investigating chrono-nutrition factors in pregnant populations.

Thus, to address these research gaps, the investigators aim to establish a new cohort study to investigate the relationship between chrono-nutrition factors during pregnancy and maternal GDM, glycemic parameters, and gestational weight gain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Women aged 20 years or older.
  • Pregnancy duration between 10 and 15 weeks.

排除标准

  • Diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes.
  • Currently taking medications that may affect glucose metabolism (e.g., metformin).
  • Irregular working schedule, such as shift work.
  • Presence of a multiple pregnancy.

结局指标

主要结局

Gestational weight gain

时间窗: 1 minutes

Institute of Medicine guideline will be applied to classify gestational weight gain adequacy based on pre-pregnancy body mass index categories.

Glycemic Parameters

时间窗: 2 hours

Values derived from oral glucose tolerance test (OGTT), including fasting, 1-hour, and 2-hour glucose levels, and gestational diabetes diagnosis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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