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Evaluation of clinical effects and POPs-related mechanisms of vegan diet among Patients with Type 2 Diabetes

Status Approved

  • First Submitted Date

    2016/01/11

  • Registered Date

    2016/01/14

  • Last Updated Date

    2016/01/14

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0001771
    Unique Protocol ID KNUH 2012-03-032
    Public/Brief Title Evaluation of clinical effects and persistent organic pollutants (POPs)-related mechanisms of vegan diet among patients with diabetes
    Scientific Title Evaluation of clinical effects and POPs-related mechanisms of vegan diet among Patients with Type 2 Diabetes
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KNUH 2012-03-032
    Approval Date 2012-04-03
    Institutional Review Board Name Institutional Review Board of Kyungpook National University Hospital
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Duk-Hee Lee
    Title M.D., Ph.D.
    Telephone +82-53-420-4866
    Affiliation Kyungpook National University Hospital
    Address 130 Dongdeok-ro, Jung-gu, Daegu, Korea
    Contact Person for Public Queries
    Name Yu-Mi Lee
    Title M.D.
    Telephone +82-53-420-4862
    Affiliation Kyungpook National University
    Address 680 Gukchaebosang-ro, Jung-gu, Daegu, Korea
    Contact Person for Updating Information
    Name Yu-Mi Lee
    Title M.D.
    Telephone +82-53-420-4862
    Affiliation Kyungpook National University
    Address 680 Gukchaebosang-ro, Jung-gu, Daegu, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2012-04-03 Actual
    Target Number of Participant 106
    Primary Completion Date 2012-10-25 , Actual
    Study Completion Date 2013-01-29 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Kyungpook National University
    Recruitment Status Completed
    Date of First Enrollment 2012-04-03 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID A111716
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kyungpook National University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Recent some studies have suggested that vegetarian and vegan diet have health benefits for a control and management of type 2 diabetes. We tried to evaluate a glycemic control effects of vegan diet and conventionally recommended diabetic diet by using randomized clinical trial. Participants with type 2 diabetes will be randomly assigned to a vegan diet group or a conventional diet group recommended by the Korean Diabetes Association 2011 for 12 weeks. 
    · Primary endpoint: a change of HbA1c during 12 weeks in two groups
    · Secondary endpoint: a change of BMI, waist circumference, blood pressure, and lipid control during 12 weeks in two groups
    
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Prevention
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Others (Diet)
    Intervention Description
    a 12-week Randomized Clinical Trial
    participants: previously diagnosed with type 2 diabetes 
    1) Experimental group: vegan diet consisted of whole grains, vegetables, fruit, and legumes
    2) Control group: conventional diet followed treatment guidelines for diabetes recommended by Korean Diabetic Association (KDA) 2011 
    Number of Arms 2
    Arm 1

    Arm Label

    vegan diet group

    Target Number of Participant

    53

    Arm Type

    Experimental

    Arm Description

    Participants were asked to follow vegan diet consisted of whole grains, vegetables, fruit, and legumes: 1) ingest unpolished rice; 2) avoid polished rice; 3) avoid processed food made of rice flour or wheat flour; 4) avoid all animal food products (i.e., meat, poultry, fish, daily goods, and eggs); 5) recommended to favor low-glycemic index foods (e.g., legumes, legumes-based food, green vegetables, and seaweed). Participants were mainly educated the diet to should avoid eat rather than should eat. Amount and frequency of food consumption, energy intake and portion sizes were not restricted.
    Arm 2

    Arm Label

    conventional diet group followed treatment guidelines for diabetes recommended by Korean Diabetic Association (KDA)

    Target Number of Participant

    53

    Arm Type

    Active comparator

    Arm Description

    The conventional diet followe treatment guidelines for diabetes recommended by Korean Diabetic Association (KDA) 2011.  Participants asked to 1) restrict individualized daily energy intake based on body weight, physical activity, a need for weight control and compliance; 2) 50-60% carbohydrate, 15-20% protein if renal function is normal, < 25% fat, <7% saturated fat, minimize trans-fat intake, and cholesterol ≤200 mg/day
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E11.9)Type 2 diabetes mellitus, without complications 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    30Year~70Year

    Description

    · women aged from 30 to 70 years old; 
    · use of hypoglycemic medications for ≥ 6 months
    · 6.5% ≤ glycosylated hemoglobin (HbA1c) ≤ 11.0%
    Exclusion Criteria
    · increased dose of hypoglycemic medication or add a new drug during recent 2 months
    · smoker or drinker
    · current vegetarian
    · pregnancy
    · severe complications (e.g.,chronic renal failure)
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome clinical-equivalence
    Primary Outcome(s) 1
    Outcome
    change of HbA1c levels
    Timepoint
    after 12 weeks
    Secondary Outcome(s) 1
    Outcome
    change of body mass index
    Timepoint
    after 12 weeks
    Secondary Outcome(s) 2
    Outcome
    change of waist circumference
    Timepoint
    after 12 weeks
    Secondary Outcome(s) 3
    Outcome
    change of triglycerides levels
    Timepoint
    after 12 weeks
    Secondary Outcome(s) 4
    Outcome
    change of LDL-choleaterol levels
    Timepoint
    after 12 weeks
    Secondary Outcome(s) 5
    Outcome
    change of HDL-choleaterol levels
    Timepoint
    after 12 weeks
    Secondary Outcome(s) 6
    Outcome
    change of fasting blood glucose levels
    Timepoint
    after 12 weeks
    Secondary Outcome(s) 7
    Outcome
    change of systolic blood pressure
    Timepoint
    after 12 weeks
    Secondary Outcome(s) 8
    Outcome
    change of diastolic blood pressure
    Timepoint
    after 12 weeks
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration

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