Records View

Prospective study for the comprehensive evaluation of metabolic surgery : Multi-center, Cohort study

Status Approved

  • First Submitted Date

    2020/05/19

  • Registered Date

    2020/05/20

  • Last Updated Date

    2020/05/19

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 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
    KCT0005044
    Unique Protocol ID 2019-11-028
    Public/Brief Title Prospective study for the comprehensive evaluation of metabolic surgery : Multi-center, Cohort study
    Scientific Title Prospective study for the comprehensive evaluation of metabolic surgery : Multi-center, Cohort study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Submitted pending
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2019-11-028
    Approval Date 2020-03-16
    Institutional Review Board Name Inha University Hospital, Institutional Review Board
    Institutional Review Board Address 27, Inhang-ro, Jung-gu, Incheon
    Institutional Review Board Telephone 032-890-3691
    Data Monitoring Committee No
  • 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 Yoonseok Heo
    Title Professor
    Telephone +82-32-890-3431
    Affiliation Inha University
    Address 27, Inhang-ro, Jung-gu, Incheon, Republic of Korea
    Contact Person for Public Queries
    Name YoonKyeong Kim
    Title Study Coordinater
    Telephone +82-32-890-1146
    Affiliation Inha University Hospital
    Address 27, Inhang-ro, Jung-gu, Incheon, Republic of Korea
    Contact Person for Updating Information
    Name YoonKyeong Kim
    Title Study Coordinater
    Telephone +82-32-890-1146
    Affiliation Inha University Hospital
    Address 27, Inhang-ro, Jung-gu, Incheon, Republic of 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 Multi-center Number of center : 14
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-02 Anticipated
    Target Number of Participant 400
    Primary Completion Date 2023-01-31 , Anticipated
    Study Completion Date 2023-02-28 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Inha University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-02 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Seoul National University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Seoul National University Bundang Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Soon Chun Hyang University Hospital Seoul
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Chung-Ang Univerisity Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Koera University Guro Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Keimyung University Dongsan Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Asan Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Yonsei University Health System, Gangnam Severance Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 10
    Name of Study The Catholic University of Korea, Seoul St. Mary's Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 11
    Name of Study Hanyang University Seoul Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 12
    Name of Study Kyung Hee University Hospital at Gangdong
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 13
    Name of Study Kyungpook National University Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
    Recruitment Status by Participating Study Site 14
    Name of Study Kosin University Gospel Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-06-09 ,
  • 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 Korea Centers for Disease Control and Prevention
    Organization Type Government
    Project ID 2020-ER6403-00
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Inha University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The Bariatric surgery has been defined as the only effective means for treating severe obesity on a long term basis and metabolic surgery is recommended as one of the most effective treatment for the patients of type 2 diabetes mellitus with class I obesity. So called, Bariatric and metabolic surgery has effect on both conditions as well as other metabolic diseases. Nowadays, almost countries and medical societies have agreed metabolic and bariatric surgery as one of best tools for treating severe obesity and obese type 2 diabetes and along with this situation, Korean Government approved to cover metabolic and bariatirc surgery with national insurance since Jan. 2019. Therefore, the demand for metabolic surgery is increasing and the it is needed immediately to evaluate the safety, effectiveness, adverse effects, complications, cost analysis in Korean patients because these diseases are recognized to have the different presentation by their race. Also, These diseases need long term results. 
    We are planning a multi-institute prospective cohort study of Korean patients who have the conditions for the criteria for insurance coverage and be receives the laparoscopic gastric bypass and laparoscopic sleeve gastrectomy, both of which are the most common metabolic and bariatric surgery in the world, collect long term clinical data and human biological materials and analyze them. 
    1. We try to evaluate the relevance of the criteria on insurance coverage of Korean Government, complications of the surgery, and to propose the better surgery for Korean patients, preventive method for complications. 2. Additionally, we collect the patients derived materials such as serum, urine, stool, fat tissue and high quality data for the study of mechanisms in Korean patients with obesity and diabetes, which are diseases with racial differences, and for follow-up studies to search for various predictors.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 400
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Metabolic surgery treatment group

    Cohort/Group Description

    severely obese patient with consent who received gastric bypass or sleeve gastrectomy. After bariatric surgery, we will assess and investigate the change of body weight and quality of life as well as the change of co-morbidities such as type 2 diabetes, hypertension, hyperlipidemia, fatty liver, sleep apnea, polycystic ovarian syndrome. As for the study of weight change, we include waist and hip circumference and as for Quality of Life, EuroQuality of Life five dimensions questionnaire (EQ-5D) , Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite), Obesity-related Psychosocial Problems scale (OP scale), Bariatric Analysis and Reporting Outcome System (BAROS) will be used. As for co-morbidities, as follows: for type 2 Diabetes Mellitus, HbA1C, oral glucose tolerance test, change of medications / for hypertension, blood pressure and medications / for hyperlipidemia, lipid profile and medicaitons / for fatty liver, change of Housefield unit on CT / for sleep apnea, change of polysomnography / for polycystic ovarian syndrome, change of the hormone profile.
    Biospecimen
    Collection & Archiving
    : DNA Collect & Archive: Sample without DNA
    Biospecimen Description
    Serum, Subcutaneous fat tissue, Visceral fat tissue, Liver tissue, Urine, Stool
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    inclusion and exclusion criteria
    patients aged 20–65 years with a body mass index of ≥35 kg/m2 alone or a body mass index of ≥30 kg/m2 plus comorbidities (hypertension, glucose intolerance, dyslipidaemia and sleep apnea) or type 2 diabetes with body mass index  over 27.5 kg/m2
    Sampling Method
    agreement for informed consent
    Non-probablity sampling : purposive sampling
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E66.9)Obesity, unspecified 

    고도비만
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~65Year

    Description

    ①  The patients aged 20–65 years with a body mass index of ≥35 kg/m2 alone or a body mass index of ≥30 kg/m2 plus comorbidities (hypertension, glucose intolerance, dyslipidaemia and sleep apnea) or type 2 diabetes with body mass index over 27.5 kg/m2, who visit the participating out patient clinics to consider bariatric surgery 
    ② ASA score (American society of anesthesiology) : class I - III 
    ③  agreement for informed consent after full explanation
    Exclusion Criteria
    ① previous bariatric or metabolic surgery 
    ② malignancy in 5 years 
    ③ vulnerable study participiants 
    ④ paticipients for other studies within 3 months
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    rate of weight loss(%), rate of waist circumference (%)
    Timepoint
    postoperative 48 week
    Secondary Outcome(s) 1
    Outcome
    remission or improvement of type 2 diabetes, hypertension, hyperlipidemia, sleep apnea, polycystic ovary syndrome
    Timepoint
    postoperative 48 week
    Secondary Outcome(s) 2
    Outcome
    rate of morbidity and mortality
    Timepoint
    postoperative 48 week
  • 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 No
  • 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 No
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동