<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03023293</url>
  </required_header>
  <id_info>
    <org_study_id>LCai</org_study_id>
    <nct_id>NCT03023293</nct_id>
  </id_info>
  <brief_title>Effects and Mechanisms of n-3 PUFAs and Irisin on Abnormal Glucose Metabolism After GDM.</brief_title>
  <official_title>Effects and Mechanisms of n-3 Polyunsaturated Fatty Acids and Irisin on the Incidence of Abnormal Glucose Metabolism After Gestational Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to clarify the relationship between n-3 PUFA and irisin in&#xD;
      regulating the glucose metabolism in GDM patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gestational diabetes mellitus (GDM) is an important risk factor for type 2 diabetes in women.&#xD;
      Studies have shown that n-3 polyunsaturated fatty acids (n-3 PUFA) are associated with&#xD;
      improving insulin resistance and prevent type 2 diabetes in the general population; a newly&#xD;
      discovered myokine, irisin, is associated with reduced insulin resistance and plays an&#xD;
      important role in human glucose metabolism; and results from cell studies suggested that n-3&#xD;
      PUFA might increase the expression of irisin. Therefore, the investigators hypothesize that&#xD;
      n-3 PUFA could improve glucose metabolism via the IRS-1/PI3K/AKT insulin signaling pathway by&#xD;
      increasing expression of irisin and thus improving postpartum glucose metabolism in women&#xD;
      with GDM. In order to test this hypothesis, the investigators plan to establish a prospective&#xD;
      GDM cohort and collect related information at 24-28 weeks' gestation, 42 days postpartum, 1&#xD;
      year postpartum and 2 years postpartum, respectively. Then the following would be tested: the&#xD;
      changes of n-3 PUFA and irisin during pregnancy and after delivery, and their association&#xD;
      with postpartum abnormal glucose metabolism; and the correlation of n-3 PUFA and irisin.&#xD;
      Furthermore, using a cell model of insulin resistance the investigators would examine the&#xD;
      dose-response and time-response relationships between n-3 PUFA and irisin, and next explore&#xD;
      the role of irisin in n-3 PUFA regulation of IRS-1/PI3K/AKT insulin signaling pathway. This&#xD;
      study would help to clarify the relationship between n-3 PUFA and irisin in regulating the&#xD;
      glucose metabolism, and might provide scientific evidence for the prevention of type 2&#xD;
      diabetes after GDM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 10, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 5, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>postpartum glucose metabolism</measure>
    <time_frame>during 2 years postpartum</time_frame>
    <description>We will measure the glucose metabolism by OGTT.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1285</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>gestational diabetes mellitus</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>n-3 PUFAs consumption and irisin</intervention_name>
    <description>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</description>
    <arm_group_label>gestational diabetes mellitus</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      the status of n-3 polyunsaturated fatty acids and irisin in plasma/serum/eryhrocyte membrane.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant women with gestational diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with gestational diabetes mellitus were screened by The Guidelines for&#xD;
             diagnosis and treatment of gestational diabetes mellitus in China in 2014.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 20 years or ≥ 45 years;&#xD;
&#xD;
          -  women with diabetes, cardiovascular disease, thyroid disease, blood disease and&#xD;
             polycystic ovary syndrome before pregnancy;&#xD;
&#xD;
          -  multiple pregnancy and assisted reproductive technology pregnancy;&#xD;
&#xD;
          -  women with severe postpartum endocrine disorders and diseases, such as pancreatitis,&#xD;
             hyperthyroidism, nephritis;&#xD;
&#xD;
          -  infection during pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Cai</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weijia, Wu</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>21677058</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21775559</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21593505</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26228794</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24850254</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23107305</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Li Cai</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>n-3 polyunsaturated fatty acids</keyword>
  <keyword>irisin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03023293
org study id: LCai
nct id: NCT03023293
lead sponsor: 
has dmc: No
The purpose of this study is to clarify the relationship between n-3 PUFA and irisin in
      regulating the glucose metabolism in GDM patients.
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.
observational model: Cohort
time perspective: Prospective
measure: postpartum glucose metabolism
time frame: during 2 years postpartum
description: We will measure the glucose metabolism by OGTT.
arm group label: gestational diabetes mellitus
description: 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.
intervention type: Other
intervention name: n-3 PUFAs consumption and irisin
description: 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
arm group label: gestational diabetes mellitus
the status of n-3 polyunsaturated fatty acids and irisin in plasma/serum/eryhrocyte membrane.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Li Cai
role: Principal Investigator
affiliation: Sun Yat-sen University
facility: 
country: China
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.
PMID: 21677058
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.
PMID: 21775559
citation: 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
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.
PMID: 26228794
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.
PMID: 24850254
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.
PMID: 23107305
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Li Cai
investigator title: Principal Investigator
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
sharing ipd: Undecided