<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/NCT03259321</url>
  </required_header>
  <id_info>
    <org_study_id>Cohort_PUFA_T2D</org_study_id>
    <nct_id>NCT03259321</nct_id>
  </id_info>
  <brief_title>Fish, Polyunsaturated Fatty Acids Intake and Type 2 Diabetes</brief_title>
  <official_title>Fish, Polyunsaturated Fatty Acids Intake and Type 2 Diabetes in CHNS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Health and Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of type 2&#xD;
      diabetes (T2D) is heavily debated but evidence from large populations in China is scant. We&#xD;
      aim to use data from the China Health and Nutrition Survey (CHNS) to assess the long-term&#xD;
      association between fish, PUFA intake and T2D risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of T2D is&#xD;
      heavily debated but evidence from large populations in China is still lacking. We aim to&#xD;
      utilize data from China Health and Nutrition Survey (CHNS, 1997-2011). We will calculate&#xD;
      cumulative means of fish and PUFA intake based on 3-day food records in each wave.&#xD;
      Sex-specific Cox regression models will be used to estimate relative risk of T2D. Results&#xD;
      from this work will provide epidemiological evidence for improving recommendations on fish&#xD;
      and PUFA intake for Chinese in dietary guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1989</start_date>
  <completion_date type="Actual">December 31, 2012</completion_date>
  <primary_completion_date type="Actual">December 31, 2011</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>Type 2 diabetes</measure>
    <time_frame>From entry into the study (baseline: 1997-2009) until 2011</time_frame>
    <description>Incidence of type 2 diabetes, on basis of self-reported physician diagnosis, fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 6.5%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fish and polyunsaturated fatty acids intake</measure>
    <time_frame>From entry into the study (baseline: 1997-2009) until 2011</time_frame>
    <description>Cumulative averages of fish and PUFA intake based on 3-day 24-hr recall in each wave</description>
  </secondary_outcome>
  <enrollment type="Actual">15100</enrollment>
  <condition>Type2 Diabetes</condition>
  <eligibility>
    <study_pop>
      <textblock>
        CHNS is an ongoing, large-scale, household-based cohort starting in 1989. The survey used a&#xD;
        multi-stage, random cluster process to draw a sample of 9 provinces and municipal cities,&#xD;
        which take up about half of Chinese population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged ≥20 with complete data on diet and follow-up time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Missing information for Type 2 diabetes&#xD;
&#xD;
          -  Type 2 diabetes&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 21, 2017</last_update_submitted>
  <last_update_submitted_qc>August 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>Jingjing Jiao</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Fish</keyword>
  <keyword>Polyunsaturated fatty acids</keyword>
  <keyword>CHNS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT03259321
org study id: Cohort_PUFA_T2D
nct id: NCT03259321
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of type 2
      diabetes (T2D) is heavily debated but evidence from large populations in China is scant. We
      aim to use data from the China Health and Nutrition Survey (CHNS) to assess the long-term
      association between fish, PUFA intake and T2D risk.
The role of fishery diet and polyunsaturated fatty acids (PUFA) in the development of T2D is
      heavily debated but evidence from large populations in China is still lacking. We aim to
      utilize data from China Health and Nutrition Survey (CHNS, 1997-2011). We will calculate
      cumulative means of fish and PUFA intake based on 3-day food records in each wave.
      Sex-specific Cox regression models will be used to estimate relative risk of T2D. Results
      from this work will provide epidemiological evidence for improving recommendations on fish
      and PUFA intake for Chinese in dietary guidelines.
observational model: Cohort
time perspective: Prospective
measure: Type 2 diabetes
time frame: From entry into the study (baseline: 1997-2009) until 2011
description: Incidence of type 2 diabetes, on basis of self-reported physician diagnosis, fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 6.5%
measure: Fish and polyunsaturated fatty acids intake
time frame: From entry into the study (baseline: 1997-2009) until 2011
description: Cumulative averages of fish and PUFA intake based on 3-day 24-hr recall in each wave
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Zhejiang University
investigator full name: Jingjing Jiao
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2