n-3 PUFAs, Irisin and Maternal Glucose Metabolism From Pregnancy to Postpartum

April 11, 2026 updated by: Li Cai, Sun Yat-sen University

Effects and Mechanisms of n-3 Polyunsaturated Fatty Acids and Irisin on Maternal Abnormal Glucose Metabolism From Pregnancy to Postpartum

This study aims to investigate the associations of maternal nutritional status during pregnancy and postpartum periods with postpartum abnormal glucose metabolism in Guangzhou pregnant women. Additionally, it seeks to explore the relationships between maternal nutritional status (pre- and postnatal) and offspring health outcomes, including physical growth, neurodevelopment, and common childhood diseases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gestational diabetes mellitus (GDM) is a well-established risk factor for the future development of type 2 diabetes in women. However, abnormal glucose metabolism is not exclusive to women with GDM; it can also occur during pregnancy and the postpartum period in those without a history of GDM. Recent studies have indicated that n-3 polyunsaturated fatty acids (n-3 PUFAs) can ameliorate insulin resistance and contribute to the prevention of type 2 diabetes in the general population. Concurrently, the novel myokine irisin has been shown to reduce insulin resistance and plays a significant regulatory role in human glucose metabolism. Ex vivo cellular studies further suggest that n-3 PUFAs can promote irisin expression. Based on this evidence, we hypothesize that n-3 PUFAs may improve postpartum glucose metabolism in women by upregulating irisin expression and subsequently activating the IRS-1/PI3K/AKT insulin signaling pathway. To test this hypothesis, a prospective cohort named Yuexiu Birth Cohort was established. The inclusion criteria were as follows: a) age 20-45 years; b) no pre-pregnancy history of diabetes, cardiovascular disease, thyroid disease, hematological disease, polycystic ovary syndrome, pregnancy-related infections, or psychiatric disorders; c) singleton pregnancy. This natural population cohort included both women with and without GDM. Follow-up data were collected at multiple time points: at 20-28 weeks of gestation (baseline: sociodemographic characteristics, lifestyle factors, anthropometric measurements, and fasting venous blood samples for assessment of glucose and lipid metabolism, erythrocyte membrane n-3 PUFA levels, and irisin levels); at 42 days postpartum (lifestyle and dietary habits, anthropometric measurements, fasting blood glucose and irisin levels); and during child follow-up at 6 months, 2 years, 3-4 years, and 5 years of age (evaluation of child growth, allergic diseases, and neuropsychological development, among other outcomes). The specific research objectives include: a) investigating the longitudinal trajectories of n-3 PUFAs and irisin from pregnancy to the postpartum period and their association with postpartum abnormal glucose metabolism (encompassing all postpartum women, not limited to those with a history of GDM); b) analyzing the correlation between n-3 PUFA and irisin levels; c) assessing the associations between maternal perinatal nutritional status (e.g., n-3 PUFA levels, dietary patterns, and other nutrients) and offspring health outcomes (including growth trajectories, neurodevelopment such as executive function and emotional/behavioral problems, and common diseases such as allergies). This study aims to systematically evaluate the perinatal nutritional status of pregnant women in Guangzhou, elucidate its associations with postpartum abnormal glucose metabolism and offspring health outcomes (growth, neuropsychological development, common diseases, etc.), and unravel the mechanistic link between n-3 PUFAs and irisin in the regulation of glucose metabolism in the general pregnant population. The findings are expected to provide a scientific basis for the prevention of postpartum type 2 diabetes and the promotion of early childhood health development.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1122

Contacts and Locations

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

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 44 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women with or without gestational diabetes mellitus (GDM) and their offspring.

Description

Inclusion Criteria:

  • Age between 20 and 45 years (inclusive).
  • Singleton pregnancy.
  • Free from the following pre-pregnancy or pregnancy-related conditions:

pregestational diabetes mellitus, cardiovascular disease, thyroid disease, hematological disease, polycystic ovary syndrome, infection during pregnancy, or mental disorder.

- Note: Women who meet all of the above criteria are eligible for the study, regardless of whether they have gestational diabetes mellitus (GDM) or not.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No treatment
This cohort study have any no treatment.
Other: No intervention
This cohort study have any no intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maternal glucose metabolism
Time Frame: Gestation (24-28 weeks) and, for fasting glucose, also at 42 days postpartum.
Maternal glycemic indicators measured during pregnancy (24-28 weeks of gestation) using a 75g oral glucose tolerance test (OGTT), including fasting plasma glucose (FPG), 1-hour post-load glucose, 2-hour post-load glucose, and hemoglobin A1c (HbA1c). Fasting insulin levels are measured by enzyme-linked immunosorbent assay (ELISA), and insulin resistance is estimated using the homeostasis model assessment of insulin resistance (HOMA-IR).
Gestation (24-28 weeks) and, for fasting glucose, also at 42 days postpartum.
Offspring physical growth and development
Time Frame: Birth, 6 months, 2 years, 3-4 years, and 5 years of age.
Including weight, length/height, head circumference, body mass index (BMI), and growth trajectories from birth to 5 years of age.
Birth, 6 months, 2 years, 3-4 years, and 5 years of age.
Offspring neuropsychological development
Time Frame: 2 years, 3-4 years, and 5 years of age.
Including executive function, emotional and behavioral problems (e.g., Strengths and Difficulties Questionnaire), developmental milestones (e.g., Ages and Stages Questionnaire), and other neuropsychological assessments at 2, 3-4, and 5 years of age.
2 years, 3-4 years, and 5 years of age.
Offspring allergic diseases
Time Frame: 6 months, 2 years, and 3-4 years.
Including physician-diagnosed or parent-reported eczema, food allergy, atopic dermatitis, allergic rhinitis, and asthma during the first 5 years of life.
6 months, 2 years, and 3-4 years.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal postpartum weight
Time Frame: 42 days postpartum.
Postpartum weight (kg) measured at 42 days postpartum.
42 days postpartum.
Maternal postpartum blood pressure
Time Frame: 42 days postpartum.
Postpartum blood pressure (systolic and diastolic, mmHg) measured at 42 days postpartum.
42 days postpartum.
Offspring vision problems
Time Frame: 3-4 years and 5 years of age.
Including visual acuity, refractive errors, or other vision-related conditions assessed at 3-4 and 5 years of age.
3-4 years and 5 years of age.
Offspring dental caries
Time Frame: 3-4 years and 5 years of age.
Presence of dental caries, decayed/missing/filled teeth (dmft index), and related dental treatment history reported by parents or assessed at 3-4 and 5 years of age.
3-4 years and 5 years of age.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Li Cai, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YXBCS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Neurodevelopmental Disorders

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings