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NCT Number: NCT06215352

Influence of Chrono-nutrition Factors and Temporal Dietary Patterns on Glycemic Parameters During Pregnancy.

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

Location status: Recruiting

Location contact

Yi-Yun Tai, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Chrono-nutrition factors

Other

Dietary records would be used to assess the chrono-nutrition factors such as night eating, breakfast skipping, meal frequency, and daily fasting.

Primary outcomes

  1. Glycemic Parameters

    Time frame: 2 hours

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

  2. Gestational weight gain

    Time frame: 1 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ling-Wei Chen, Ph.D.

CONTACT

[email protected]

+886-3366-9537

Yu-En Chen

CONTACT

[email protected]

+886-3366-9537

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 22, 2024
Registry last updated
Jan 25, 2024

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.

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