UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034501
Receipt No. R000037802
Scientific Title A study of relations between fatty liver and annual changes of weight and BMI.
Date of disclosure of the study information 2018/10/15
Last modified on 2019/08/10 (Ver. 7)

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Basic information
Public title A study of relations between fatty liver and annual changes of weight and BMI.
Acronym A study of relations between fatty liver and annual changes of weight and BMI.
Scientific Title A study of relations between fatty liver and annual changes of weight and BMI.
Scientific Title:Acronym A study of relations between fatty liver and annual changes of weight and BMI.
Region
Japan

Condition
Condition fatty liver
Classification by specialty
Medicine in general Gastroenterology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Studying the relationship between weight and ultrasonography findings of fatty liver.
Basic objectives2 Others
Basic objectives -Others Studying the relationship between weight change and ultrasonography findings of fatty liver.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Examining the relationship between the time course of weight change and fatty liver onset. Items are as follows. Ultrasonography, sex, age, height, weight, BMI, AST, ALT, gamma-GTP.
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
100 years-old >
Gender Male and Female
Key inclusion criteria participants who visited our institute for medical checkup.
Key exclusion criteria 1,The person who expressed refusal to participate.
2,Heavy drinker.(Alcohol over 30g/day)
3,chronic liver disease of HBV and HCV.
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Izumi
Organization Takagi hospital
Division name Internal medicine
Zip code 831-0016
Address Sakemi 141-11, Okawa-city, Fukuoka
TEL 0944-87-0001
Email kenizumi@kouhoukai.org

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Izumi
Organization Takagi hospital
Division name Internal medicine
Zip code 831-0016
Address Sakemi 141-11, Okawa-city, Fukuoka
TEL 0944-87-0001
Homepage URL
Email kenizumi@kouhoukai.org

Sponsor
Institute Takagi hospital
Institute
Department

Funding Source
Organization Takagi 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 Takagi Hospital IRB
Address SAKEMI 141-11, OOKAWA city, FUKUOKA, JAPAN
Tel 0944870001
Email rinri-shinsa@kouhoukai.org

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 10 Month 15 Day

Related information
URL releasing protocol https://www.ningen-dock.jp/wp/common/data/journal/dock34_1.pdf
Publication of results Published

Result
URL related to results and publications https://www.ningen-dock.jp/wp/common/data/journal/dock34_1.pdf
Number of participants that the trial has enrolled 410
Results 
There is a possibility of people with a BMI of less than 25 kg/m2 developing
NAFLD if their weight increases greatly and with a 4-7% bodyweight gain, a normal liver
may change to the NAFLD state. However, our data is insufficient to make a definite conclusion. so further studies are needed.
Results date posted
2019 Year 08 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
The participants of our study were people who visited our hospital for a Ningen
Dock-style health check-up from 2008 to 2016 and underwent abdominal ultrasonography(US) as part of it. From the US images in the Ningen Dock data, those double negative for fatty liver for at least 2 consecutive years and then double positive for at least 2 consecutive years were determined. After excluding those with over 20 g of alcohol consumption, those post-pancreaticoduodenectomy and those with hepatitis type B virus or hepatitis type C virus infection, 215 people remained for our study.
Participant flow 
The participants of our study were people who visited our hospital for a Ningen
Dock-style health check-up from 2008 to 2016 and underwent abdominal ultrasonography
(US) as part of it. 
Data were excluded those with over 20 g of alcohol consumption, those
post-pancreaticoduodenectomy and those with hepatitis type B virus or hepatitis type C virus
infection.
So 14,989 people's data (Average 53.0 years, 6,523 men, 8,466 women) were obtained. 
From the US images in the Ningen Dock data, those double negative for
fatty liver for at least 2 consecutive years and then double positive for at least 2 consecutive
years were determined.
215 people remained for our study. We studied their annual changes in bodyweight
and BMI.(Average age 50.5 years, 106 men, 109 women)
In addition, 379 people's data were examined in the last nine years without fatty liver (average age 53.4 years, 90 men, 289 women).
Among them, 195 data were obtained who adjusted sex and age (average age 52.6 years old, 90 men, 105 women) with 215 people's data having fatty liver.
We compared two groups to study annual change of BMI in developing NAFLD.
Adverse events 
Sone
Outcome measures 
Annual data of age, sex, height, weight, BMI, AST, ALT, gamma GTP
Plan to share IPD None
IPD sharing Plan description None

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 06 Month 04 Day
Date of IRB
2018 Year 06 Month 04 Day
Anticipated trial start date
2018 Year 07 Month 07 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Completed

Management information
Registered date
2018 Year 10 Month 15 Day
Last modified on
2019 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037802