Effects and Mechanisms of n-3 PUFAs and Irisin on Abnormal Glucose Metabolism After GDM.

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: n-3 PUFAs consumption and irisin

• Registration Number: NCT03023293
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The purpose of this study is to clarify the relationship between n-3 PUFA and irisin in regulating the glucose metabolism in GDM patients.

Detailed Description

Gestational diabetes mellitus (GDM) is an important risk factor for type 2 diabetes in women. Studies have shown that n-3 polyunsaturated fatty acids (n-3 PUFA) are associated with improving insulin resistance and prevent type 2 diabetes in the general population; a newly discovered myokine, irisin, is associated with reduced insulin resistance and plays an important role in human glucose metabolism; and results from cell studies suggested that n-3 PUFA might increase the expression of irisin. Therefore, the investigators hypothesize that n-3 PUFA could improve glucose metabolism via the IRS-1/PI3K/AKT insulin signaling pathway by increasing expression of irisin and thus improving postpartum glucose metabolism in women with GDM. In order to test this hypothesis, the investigators plan to establish a prospective GDM cohort and collect related information at 24-28 weeks' gestation, 42 days postpartum, 1 year postpartum and 2 years postpartum, respectively. Then the following would be tested: the changes of n-3 PUFA and irisin during pregnancy and after delivery, and their association with postpartum abnormal glucose metabolism; and the correlation of n-3 PUFA and irisin. Furthermore, using a cell model of insulin resistance the investigators would examine the dose-response and time-response relationships between n-3 PUFA and irisin, and next explore the role of irisin in n-3 PUFA regulation of IRS-1/PI3K/AKT insulin signaling pathway. This study would help to clarify the relationship between n-3 PUFA and irisin in regulating the glucose metabolism, and might provide scientific evidence for the prevention of type 2 diabetes after GDM.

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-18
• Study Start: 2017-03-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11
• Primary Completion: 2019-04-05
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1285

Inclusion Criteria

• Pregnant women with gestational diabetes mellitus were screened by The Guidelines for diagnosis and treatment of gestational diabetes mellitus in China in 2014.

Exclusion Criteria

• age < 20 years or ≥ 45 years;
• women with diabetes, cardiovascular disease, thyroid disease, blood disease and polycystic ovary syndrome before pregnancy;
• multiple pregnancy and assisted reproductive technology pregnancy;
• women with severe postpartum endocrine disorders and diseases, such as pancreatitis, hyperthyroidism, nephritis;
• infection during pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
gestational diabetes mellitus	n-3 PUFAs consumption and irisin	The investigators plan to establish a prospective GDM cohort and collect n-3 PUFAs consumption and irisin information at 24-28 weeks'gestation, 42 days postpartum, 1 year postpartum and 2 years postpartum, respectively.

Primary Outcome Measures

Name	Time	Method
postpartum glucose metabolism	during 2 years postpartum	We will measure the glucose metabolism by OGTT.

Trial Locations

Locations (1)

Weijia, Wu; 🇨🇳 Guangzhou, Guangdong, China