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

NCT03023293 | Completed

• 1 other identifier: YXBCS
• Study Type: observational
• Target: 1,122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes Mellitus; Neurodevelopmental Disorders; Postpartum Abnormal Glucose Metabolism; Child Growth and Development; Allergic Diseases; Child Emotional and Behavioral Problems

Keywords

n-3 polyunsaturated fatty acids; Dietary patterns; Nutritional status; Irisin

Outcome Measures

Primary Outcomes (4)

• Maternal glucose metabolism

  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

  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

  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

  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 Outcomes (4)

• Maternal postpartum weight

  42 days postpartum.

• Maternal postpartum blood pressure

  42 days postpartum.

• Offspring vision problems

  3-4 years and 5 years of age.

• Offspring dental caries

  3-4 years and 5 years of age.

Study Arms (1)

No treatment

This cohort study have any no treatment.

Other: No intervention

Interventions

No intervention OTHER

This cohort study have any no intervention.

No treatment

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (7)

• Villegas R, Xiang YB, Elasy T, Li HL, Yang G, Cai H, Ye F, Gao YT, Shyr Y, Zheng W, Shu XO. Fish, shellfish, and long-chain n-3 fatty acid consumption and risk of incident type 2 diabetes in middle-aged Chinese men and women. Am J Clin Nutr. 2011 Aug;94(2):543-51. doi: 10.3945/ajcn.111.013193. Epub 2011 Jun 15.

  PMID: 21677058 BACKGROUND

• Nanri A, Mizoue T, Noda M, Takahashi Y, Matsushita Y, Poudel-Tandukar K, Kato M, Oba S, Inoue M, Tsugane S; Japan Public Health Center-based Prospective Study Group. Fish intake and type 2 diabetes in Japanese men and women: the Japan Public Health Center-based Prospective Study. Am J Clin Nutr. 2011 Sep;94(3):884-91. doi: 10.3945/ajcn.111.012252. Epub 2011 Jul 20.

  PMID: 21775559 BACKGROUND

• Brostow DP, Odegaard AO, Koh WP, Duval S, Gross MD, Yuan JM, Pereira MA. Omega-3 fatty acids and incident type 2 diabetes: the Singapore Chinese Health Study. Am J Clin Nutr. 2011 Aug;94(2):520-6. doi: 10.3945/ajcn.110.009357. Epub 2011 May 18.

  PMID: 21593505 BACKGROUND

• Zhao L, Li J, Li ZL, Yang J, Li ML, Wang GL. Circulating irisin is lower in gestational diabetes mellitus. Endocr J. 2015;62(10):921-6. doi: 10.1507/endocrj.EJ15-0230. Epub 2015 Jul 29.

  PMID: 26228794 BACKGROUND

• Kuzmicki M, Telejko B, Lipinska D, Pliszka J, Szamatowicz M, Wilk J, Zbucka-Kretowska M, Laudanski P, Kretowski A, Gorska M, Szamatowicz J. Serum irisin concentration in women with gestational diabetes. Gynecol Endocrinol. 2014 Sep;30(9):636-9. doi: 10.3109/09513590.2014.920006. Epub 2014 May 22.

  PMID: 24850254 BACKGROUND

• Vaughan RA, Garcia-Smith R, Bisoffi M, Conn CA, Trujillo KA. Conjugated linoleic acid or omega 3 fatty acids increase mitochondrial biosynthesis and metabolism in skeletal muscle cells. Lipids Health Dis. 2012 Oct 30;11:142. doi: 10.1186/1476-511X-11-142.

  PMID: 23107305 BACKGROUND

• Tang N, He Y, Karatela S, Zhong J, Zeng X, Lu Q, Zhao F, Cai L. Association between erythrocyte polyunsaturated fatty acids and gestational diabetes mellitus in Chinese pregnant women. Eur J Nutr. 2025 Feb 11;64(2):87. doi: 10.1007/s00394-025-03603-2.

  PMID: 39932572 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fasting venous blood samples were collected from pregnant women at 20-28 weeks of gestation and at 42 days postpartum. The biospecimens were used to measure erythrocyte membrane fatty acids, plasma irisin, glucose, insulin, and lipid profiles. Remaining samples are stored at -80°C and may be used for future metabolomics and exposomics analyses.

MeSH Terms

Conditions

Diabetes, Gestational; Neurodevelopmental Disorders; Problem Behavior

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Li Cai

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: March 10, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (1)