UMIN-CTR Clinical Trial

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
Email	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
Email	hirofumi-i@surg.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035199