UMIN-CTR Clinical Trial

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
Last 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
Email	kayamada@hosp.ncgm.go.jp

Public contact
1st 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
Email	knohara@hosp.ncgm.go.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037098