UMIN-CTR Clinical Trial

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
Institute	Hokkaido University Graduate School
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038839