UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043179
Receipt number R000049286
Scientific Title Observational study for the effects on body weight and glycemic control by laparoscopic sleeve gastrectomy in Japanese obese patients.
Date of disclosure of the study information 2021/01/29
Last modified on 2022/03/25 15:20:25

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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 or person

Institute

Hokkaido University Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049286


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name