UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043179 |
|---|---|
| Receipt number | R000049286 |
| Scientific Title | Observational study for the effects on body weight and glycemic control by laparoscopic sleeve gastrectomy in Japanese obese patients. |
| Date of disclosure of the study information | 2021/01/29 |
| Last modified on | 2022/03/25 15:20:25 |
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Basic information
Public title
Observational study for the effects on body weight and glycemic control by laparoscopic sleeve gastrectomy in Japanese obese patients.
Acronym
Observational study by laparoscopic sleeve gastrectomy in Japanese obese patients.
Scientific Title
Observational study for the effects on body weight and glycemic control by laparoscopic sleeve gastrectomy in Japanese obese patients.
Scientific Title:Acronym
Observational study by laparoscopic sleeve gastrectomy in Japanese obese patients.
Region
| Japan |
Condition
Condition
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
The aim is to evaluate the efficacy of laparoscopic sleeve gastrectomy in Japanese obese patients on metabolic parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of body weight and BMI with laparoscopic sleeve gastrectomy.
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients who underwent laparoscopic sleeve gastrectomy for obesity
(2) Patients over 20 years old
(3) Those who have received sufficient explanation before participating in this research, and who have obtained the voluntary consent of the research subject after receiving sufficient understanding, or who do not refuse to participate in the research.
Key exclusion criteria
Patients judged to be inappropriate as research subjects
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kyu Yong |
| Middle name | |
| Last name | Cho |
Organization
Hokkaido University
Division name
Diabetes and endocrinology
Zip code
060-8648
Address
N14W5, Kita-ku, Sapporo
TEL
011-706-1161
kyuyong-cho@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Oe |
Organization
Hokkaido University Hospital
Division name
Internal medicine 2
Zip code
080-8648
Address
n14w5, kita-ku, Sapporo, Hokkaido
TEL
011-706-5915
Homepage URL
o-e.yuki@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
Hokkaido University Hospital institutional review board
Address
n14w5, kita-ku, Sapporo, Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2021 | Year | 01 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | 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
| 2021 | Year | 01 | Month | 29 | Day |
Last modified on
| 2022 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049286
