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

Gestational Diabetes Mellitus Clinical Trial

Official title:

Effects and Mechanisms of n-3 Polyunsaturated Fatty Acids and Irisin on the Incidence of Abnormal Glucose Metabolism After Gestational Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03023293
• Other study ID #: LCai
• Status: Active, not recruiting
• Start date: March 10, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1285
• Est. completion date: December 31, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Other:
• n-3 PUFAs consumption and irisin
The investigators plan to collect n-3 PUFAs and irisin information at 24-28 weeks' gestation, 42 days postpartum, 1 year postpartum and 2 years postpartum

Locations

Country	Name	City	State
China	Weijia, Wu	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postpartum glucose metabolism	We will measure the glucose metabolism by OGTT.	during 2 years postpartum