Gestational Diabetes MellitusNCT03023293
n-3 PUFAs, Irisin and Maternal Glucose Metabolism From Pregnancy to Postpartum
An observational study of Gestational Diabetes Mellitus and Neurodevelopmental Disorders, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus, Neurodevelopmental Disorders, Postpartum Abnormal Glucose Metabolism
- How many people
- 1,122 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2017to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with or without gestational diabetes mellitus (GDM) and their offspring.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus, Neurodevelopmental Disorders, Postpartum Abnormal Glucose Metabolism, Child Growth and Development, Allergic Diseases, Child Emotional and Behavioral Problems
- Being tested
- No intervention
- Keywords
- n-3 polyunsaturated fatty acids, Dietary patterns, Nutritional status, Irisin
- Medical subject headings
- Diabetes, Gestational, Neurodevelopmental Disorders, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This cohort study have any no intervention.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | This cohort study have any no treatment. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months, 2 years, and 3-4 years.
Secondary outcomes (4)
Maternal postpartum weight
Postpartum weight (kg) measured at 42 days postpartum.
Measured: 42 days postpartum.
Maternal postpartum blood pressure
Postpartum blood pressure (systolic and diastolic, mmHg) measured at 42 days postpartum.
Measured: 42 days postpartum.
Offspring vision problems
Including visual acuity, refractive errors, or other vision-related conditions assessed at 3-4 and 5 years of age.
Measured: 3-4 years and 5 years of age.
Offspring dental caries
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.
Measured: 3-4 years and 5 years of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start10 Mar 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Cai, Sun Yat-sen University
- Investigators
- Li Cai, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023293
- Sponsor's protocol ID
- YXBCS
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2017
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21677058Nanri 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.
PubMed 21775559Brostow 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.
PubMed 21593505Zhao 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.
PubMed 26228794Kuzmicki 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.
PubMed 24850254Vaughan 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.
PubMed 23107305Tang 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.
PubMed 39932572
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of n-3 Polyunsaturated Fatty Acids and Irisin on Maternal Abnormal Glucose Metabolism From Pregnancy to Postpartum
- ClinicalTrials.gov ID
- NCT03023293
- Acronym / sponsor ID
- YXBCS
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,122 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: No interventionThis cohort study have any no treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with or without gestational diabetes mellitus (GDM) and their offspring.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis cohort study have any no intervention. | Other | No treatment |
Primary outcome
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).
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.
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.
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.
4 secondary outcomes
Maternal postpartum weight
Time frame: 42 days postpartum.
Maternal postpartum blood pressure
Time frame: 42 days postpartum.
Offspring vision problems
Time frame: 3-4 years and 5 years of age.
Offspring dental caries
Time frame: 3-4 years and 5 years of age.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Background: PubMed 21677058Villegas 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.
- Background: PubMed 21775559Nanri 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.
- Background: PubMed 21593505Brostow 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.
- Background: PubMed 26228794Zhao 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.
- Background: PubMed 24850254Kuzmicki 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.
- Background: PubMed 23107305Vaughan 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.
- Derived from this study: PubMed 39932572Tang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Cai principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus and Neurodevelopmental Disorders, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal glucose metabolism (time frame: Gestation (24-28 weeks) and, for fasting glucose, also at 42 days postpartum.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03023293, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.