UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034667
Receipt number R000038839
Scientific Title Effect on liver following metabolic surgery in patients with fatty liver and type 2 diabates -Prospective cohort study-
Date of disclosure of the study information 2018/12/01
Last modified on 2022/04/12 18:40:04

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Basic information

Public title

Effect on liver following metabolic surgery in patients with fatty liver and type 2 diabates -Prospective cohort study-

Acronym

Effect on liver by metabolic surgery

Scientific Title

Effect on liver following metabolic surgery in patients with fatty liver and type 2 diabates -Prospective cohort study-

Scientific Title:Acronym

Effect on liver by metabolic surgery

Region

Japan


Condition

Condition

Patients with fatty liver and type 2 diabates

Classification by specialty

Medicine in general Endocrinology and Metabolism Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect on improvement of fatty liver between metabolic surgery and medication therapies in patients with fatty liver and type 2 diabetes.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change of hepatic steatosis and fibrosis in the blood test and image examination

Key secondary outcomes

1) Body weight, BMI and waist circumference
2) Total weight loss rate and excess weight loss rate
3) Blood pressure
4) Fasting plasma glucose
5) Adiponectin and reptin
6) Other blood and urine tests (liver, kidney, lipid, bone metabolism, nutrition, endocrine, etc)
7) Visceral fat mass and subcutaneous fat mass (HDS-2000 DUALSCAN)
8) Visceral fat mass and subcutaneous fat mass (computed tomography)
9) Body composition (InBody)
10) Dual-energy X-ray absorptiometry
11) Hepatic hepatosis and fibrosis index (calculation from blood tests)
12) Insulin kinetics with 75gOGTT
13) Liver biopsy


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients whose BMI is more than 35 kg/m2 in operative group and more than 30 kg/m2 in control group
2) Patients who are 20-year-old or older
3) Patients suspected NASH/NAFLD
4) Patients who are able to understand the study and willing to provide written informed consent

Key exclusion criteria

1) Patients who are deemed to be unsuitable by the investigator

Target sample size

40


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 Oe
Middle name
Last name Yuki

Organization

Hokkaido University Graduate School

Division name

Department of Rheumatology, Endocrinology and Nephrology

Zip code

060-8638

Address

N-15, W-7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-5915

Homepage URL


Email

o-e.yuki@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University Graduate School

Institute

Department

Personal name



Funding Source

Organization

Hokkaido University Graduate School

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 Clinical Research and Medical Innovation Center

Address

N-14, W-5, Kita-ku, Sapporo, Hokkaido, Japna

Tel

011-706-7636

Email

crjimu@hunp.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

2018 Year 12 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 12 Month 01 Day

Date of IRB

2018 Year 10 Month 30 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2020 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We evaluated the change of hepatic steatosis and fibrosis in the blood test and image examination.


Management information

Registered date

2018 Year 10 Month 26 Day

Last modified on

2022 Year 04 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038839


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name