UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030837 |
|---|---|
| Receipt number | R000035199 |
| Scientific Title | A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus (Advanced medical care A) |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2021/01/18 17:53:36 |
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Basic information
Public title
A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus (Advanced medical care A)
Acronym
A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus (Advanced medical care A)
Scientific Title
A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus (Advanced medical care A)
Scientific Title:Acronym
A phase 2 study to evaluate safety and efficacy of laparoscopic sleeve gastrectomy+duodenojejunostoy for morbid obese patients with diabetes mellitus (Advanced medical care A)
Region
| Japan |
Condition
Condition
Morbid obese patients with diabetes mellitus
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of Laparoscopic Sleeve Gastrectomy / Duodeno-Jejunal Bypass: LSG / DJB
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate safety
Confirm postoperative complications within 30 post operative days
To evaluate efficacy
HbA1c at 12months after surgery
Key secondary outcomes
To evaluate safety
1, Confirm the presence or absence of malnutrition after the operation
at 12months after surgery
To evaluate efficacy
1, Effect on weight loss
2, Confirm medication status of diabetes drugs
at 12months after surgery
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
Opetarion
Laparoscopic sleeve gastrectomy/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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, Age: 18-65 years of age
2, Gender: unquestioned
3, BMI: 32Kg/m2 or more
4, Less than 5 points in the m-ABCD score
5, including patients whose effects after laparoscopic sleeve-gastrectomy are not sufficient, satisfying above criteria 1-4
Key exclusion criteria
1, Patiens mental disorders are clearly involved in morbid obesity Background
2, Secondary obesity associated with endocrine disorders
3, Patients determined not to be expected the effect of weight loss surgery
4, Patients with severe renal dysfunction
5, Patients with severe liver failure
6, Pregnant women or women who may possibly be pregnant
7, 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 | Hirofumi |
| Middle name | |
| Last name | Imoto |
Organization
Tohoku University Hospital
Division name
Department of surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, JAPAN
TEL
022-717-7205
hirofumi-i@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Imoto |
Organization
Tohoku University Hospital
Division name
Department of surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, JAPAN
TEL
022-717-7205
Homepage URL
hirofumi-i@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
Tel
022-717-7205
hirofumi-i@surg.med.tohoku.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
| 2018 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 16 | Day |
Last modified on
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035199
