UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035768 |
|---|---|
| Receipt number | R000037098 |
| Scientific Title | A single arm study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with diabetes mellitus. |
| Date of disclosure of the study information | 2019/02/04 |
| Last modified on | 2019/05/24 12:18:19 |
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Basic information
Public title
A single arm study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with diabetes mellitus.
Acronym
A single arm study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with diabetes mellitus.
Scientific Title
A single arm study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with diabetes mellitus.
Scientific Title:Acronym
A single arm study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with diabetes mellitus.
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of Laparoscopic Sleeve Gastrectomy(LSG)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
morbidity(Clavien Dindo classification:
above gradeIIIB)
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
to performe Laparoscopic Sleeve Gastrectomy
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1,including patients whose effects after medical treatment are not sufficient(HbA1cover 7.5% for over 6months),satisfying above criteria 1-4
2, BMI:32.5-40Kg/m2
3, Performance Status:0-1
4, Age:20-60 years of age
Key exclusion criteria
1, Patients have severe mental disorders 2, Patients have alcohol dependence or drug dependence
3, Patients use immunosuppressive agents
4, Patients with severe heart and lung dysfunction or severe complications
5, Patients cannot follow medical stuff
6, Patients determined to be inappropriate as a test subject by investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Yamada |
Organization
National Center for Global Health and Medicine
Division name
Department of Surgery
Zip code
162-8655
Address
1-21-1,Toyama,Shinjuku-ku,Tokyo
TEL
03-3202-7181
kayamada@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kyoko |
| Middle name | |
| Last name | Nohara |
Organization
National Center for Global Health and Medicine
Division name
Department of Surgery
Zip code
162-8655
Address
1-21-1,Toyama,Shinjuku-ku,Tokyo
TEL
03-3202-7181
Homepage URL
knohara@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine,Center for Clinical Science
Address
1-21-1,Toyama,Shinjuku-ku,Tokyo
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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
国立研究開発法人国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 04 | 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
| 2018 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 02 | Month | 04 | Day |
Last modified on
| 2019 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037098
