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
CRIS Registration Number |
KCT0005044 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 14 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Korea Centers for Disease Control and Prevention |
Organization Type | Government |
Project ID | 2020-ER6403-00 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Inha University Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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. |
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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
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 |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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