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

NCT ID: NCT06215352

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

316 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-09

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gestational Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Chrono-nutrition factors

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ling-Wei Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Epidemiology and Preventive Medicine, National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, Zhongzheng District, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-En Chen

Role: CONTACT

+886-3366-9537

Ling-Wei Chen, Ph.D.

Role: CONTACT

+886-3366-9537

Facility Contacts

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Yi-Yun Tai, MD

Role: primary

Other Identifiers

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202301101RIND

Identifier Type: -

Identifier Source: org_study_id

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