UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035537 |
|---|---|
| Receipt number | R000040490 |
| Scientific Title | A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy with duodenojejunal bypass for obesity with diabetes mellitus |
| Date of disclosure of the study information | 2019/01/15 |
| Last modified on | 2019/01/14 19:08:22 |
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Basic information
Public title
A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy with duodenojejunal bypass for obesity with diabetes mellitus
Acronym
A phase 2 study of laparoscopic sleeve gastrectomy with duodenojejunal bypass
Scientific Title
A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy with duodenojejunal bypass for obesity with diabetes mellitus
Scientific Title:Acronym
A phase 2 study of laparoscopic sleeve gastrectomy with duodenojejunal bypass
Region
| Japan |
Condition
Condition
Morbid obesity with diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Gastrointestinal surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of laparoscopic sleeve gastrectomy with duodenojejunal bypass for morbid obesity with diabetes mellitus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Remission rate of diabetes mellitus
Key secondary outcomes
Surgical morbidity
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
Laparoscopic Sleeve Gastrectomy with Duodenojejunal Bypass
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 BMI: 35Kg/m2 or more
2 Duration of diabetes care: >> 6 months
3 ASA-PS: << Class 3
Key exclusion criteria
Severe organ dysfunction
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Inoue |
Organization
Kansai Medical University Hospital
Division name
Gastrointestinal surgery
Zip code
Address
Shinmachi 2-3-1, Hirakata city, Osaka
TEL
81728040101
inoueke@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Inoue |
Organization
Kansai Medical University Hospital
Division name
Gastrointestinal surgery
Zip code
Address
Shinmachi 2-3-1, Hirakata
TEL
81728040101
Homepage URL
inoueke@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
関西医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 15 | 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
| 2019 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 14 | Day |
Last modified on
| 2019 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040490
