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

January 10, 2019 updated by: Li Cai, Sun Yat-sen University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1285

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
        • Weijia, Wu

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

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

pregnant women with gestational diabetes mellitus

Description

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 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
gestational diabetes mellitus
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postpartum glucose metabolism
Time Frame: during 2 years postpartum
We will measure the glucose metabolism by OGTT.
during 2 years postpartum

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 (Anticipated)

April 5, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCai

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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