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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Sun Yat-sen University

Investigators

  • 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)

March 10, 2017

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimated)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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