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

January 23, 2024 updated by: National Taiwan University Hospital

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

316

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • Zhongzheng District
      • Taipei city, Zhongzheng District, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women attending first antenatal clinic visits at National Taiwan University Hospital (NTUH) will be recruited.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hours
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.
1 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Ling-Wei Chen, Ph.D., Institute of Epidemiology and Preventive Medicine, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301101RIND

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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