UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041014 |
|---|---|
| Receipt number | R000046836 |
| Scientific Title | Study of the therapeutic effects of bariatric surgery for severe obesity |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2020/07/06 15:03:17 |
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Basic information
Public title
Study of the therapeutic effects of bariatric surgery for severe obesity
Acronym
Study of the therapeutic effects of bariatric surgery for severe obesity
Scientific Title
Study of the therapeutic effects of bariatric surgery for severe obesity
Scientific Title:Acronym
Study of the therapeutic effects of bariatric surgery for severe obesity
Region
| Japan |
Condition
Condition
severe obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to elucidate the pathology of obesity by evaluating the body composition, insulin resistance, and humoral factors before and after bariatric surgery in patients undergoing briatric surgery for severe obesity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine changes in insulin resistance index by glucose clamp test before and after bariatric surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Glucose clamp tests are performed before bariatric surgery and 6 months after surgery.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing obesity reduction surgery who obtained consent to participate in the study.
Key exclusion criteria
Patients who violate any of the following are excluded from this study.
1) Diabetes patients with etiology other than type 2 diabetes
2) Patients with a history of severe ketosis, diabetic coma or precoma within the past 6 months.
3) Patients with severe infections and serious trauma
4) Pregnant women or women who may be pregnant and breast-feeding patients
5) Patients with severe liver dysfunction
6) Patients with moderate or higher renal dysfunction or end-stage renal failure on dialysis
7) Patients with heart failure (NYHA classification II-IV)
8) Patients with serious mental illness
9) Patients with a history of hypersensitivity to insulin
10) Obese patients due to abnormal endocrine hormones
11) Patients treated with steroid hormones
12) Patients who are not suitable for study participation because of medical reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Fujioka |
Organization
Tottori University Faculty of Medicine
Division name
Division of Cardiovascular Medicine and Endocrinology and Metabolism
Zip code
6838504
Address
36-1, NIshi-cho, Yonago, Tottori
TEL
0859386517
yohei_0201@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Fujioka |
Organization
Tottori University Faculty of Medicine
Division name
Division of Cardiovascular Medicine and Endocrinology and Metabolism
Zip code
6838504
Address
36-1, NIshi-cho, Yonago, Tottori
TEL
0859386517
Homepage URL
yohei_0201@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine, Division of Cardiovascular Medicine and Endocrinology and Me
Institute
Department
Personal name
Funding Source
Organization
Tottori University Faculty of Medicine, Division of Cardiovascular Medicine and Endocrinology and Me
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Certified Review Board, Tottori University Hospital
Address
36-1, NIshi-cho, Yonago, Tottori
Tel
0859387021
cert.office@ml.med.tottori-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046836
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| Registered date | File name |
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