UMIN-CTR Clinical Trial

Basic information
Public title	Observational study for the effects on body weight and glycemic control by laparoscopic sleeve gastrectomy in Japanese obese patients.
Acronym	Observational study by laparoscopic sleeve gastrectomy in Japanese obese patients.
Scientific Title	Observational study for the effects on body weight and glycemic control by laparoscopic sleeve gastrectomy in Japanese obese patients.
Scientific Title:Acronym	Observational study by laparoscopic sleeve gastrectomy in Japanese obese patients.
Region	Japan

Condition
Condition	Obesity
Classification by specialty	Medicine in general Endocrinology and Metabolism Surgery in general Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is to evaluate the efficacy of laparoscopic sleeve gastrectomy in Japanese obese patients on metabolic parameters.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The changes of body weight and BMI with laparoscopic sleeve gastrectomy.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patients who underwent laparoscopic sleeve gastrectomy for obesity (2) Patients over 20 years old (3) Those who have received sufficient explanation before participating in this research, and who have obtained the voluntary consent of the research subject after receiving sufficient understanding, or who do not refuse to participate in the research.
Key exclusion criteria	Patients judged to be inappropriate as research subjects
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kyu Yong Middle name Last name Cho
Organization	Hokkaido University
Division name	Diabetes and endocrinology
Zip code	060-8648
Address	N14W5, Kita-ku, Sapporo
TEL	011-706-1161
Email	kyuyong-cho@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Oe
Organization	Hokkaido University Hospital
Division name	Internal medicine 2
Zip code	080-8648
Address	n14w5, kita-ku, Sapporo, Hokkaido
TEL	011-706-5915
Homepage URL
Email	o-e.yuki@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hokkaido University Hospital institutional review board
Address	n14w5, kita-ku, Sapporo, Hokkaido
Tel	011-706-7636
Email	crjimu@huhp.hokudai.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	2021 Year 01 Month 29 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	Enrolling by invitation
Date of protocol fixation	2021 Year 01 Month 19 Day
Date of IRB	2021 Year 01 Month 19 Day
Anticipated trial start date	2021 Year 01 Month 19 Day
Last follow-up date	2028 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2021 Year 01 Month 29 Day
Last modified on	2022 Year 03 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049286