UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034501 |
|---|---|
| Receipt number | 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 13:50:11 |
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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
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
kenizumi@kouhoukai.org
Sponsor or person
Institute
Takagi hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037802
| Research Plan | |
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| Research case data | |
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