UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052446 |
|---|---|
| Receipt number | R000059862 |
| Scientific Title | The prospective observational study to examine the changes in metabolic and endocrinological function following bariatric surgery for severe obesity |
| Date of disclosure of the study information | 2023/10/09 |
| Last modified on | 2025/04/11 15:18:17 |
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Basic information
Public title
The prospective observational study to examine the changes in metabolic and endocrinological function following bariatric surgery for severe obesity
Acronym
The prospective observational study to examine the changes in metabolic and endocrinological function following bariatric surgery for severe obesity
Scientific Title
The prospective observational study to examine the changes in metabolic and endocrinological function following bariatric surgery for severe obesity
Scientific Title:Acronym
The prospective observational study to examine the changes in metabolic and endocrinological function following bariatric surgery for severe obesity
Region
| Japan |
Condition
Condition
Severe obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the changes in metabolic and endocrinological function following bariatric surgery for severe obesity
Basic objectives2
Others
Basic objectives -Others
Improvements in metabolic abnormalities
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement levels of HOMA-IR and QUICKI
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Participants provided written informed consent
Key exclusion criteria
Inability to participate in the study as assessed by the investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Fujishiro |
Organization
Nihon University Hospital
Division name
Department of Internal Medicine
Zip code
101-8309
Address
1-6, kandasurugadai, chiyoda-ku, tokyo
TEL
03-3293-1711
fujishiro.midori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Fujishiro |
Organization
Nihon University Hospital
Division name
Department of Internal Medicine
Zip code
101-8309
Address
1-6, kandasurugadai, chiyoda-ku, tokyo
TEL
03-3293-1711
Homepage URL
fujishiro.midori@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
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
Nihon University Hospital IRB
Address
1-6, kandasurugadai, chiyoda-ku, tokyo
Tel
03-3293-1711
fujishiro.midori@nihon-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
| 2023 | Year | 10 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2023 | Year | 10 | Month | 09 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059862
