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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040264
Receipt No. R000045856
Scientific Title Retrospective study of anthropometric indices predicting lean nonalcoholic fatty liver disease
Date of disclosure of the study information 2020/04/28
Last modified on 2020/05/19

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Basic information
Public title Retrospective study of anthropometric indices predicting lean nonalcoholic fatty liver disease
Acronym Retrospective study of anthropometric indices predicting lean nonalcoholic fatty liver disease
Scientific Title Retrospective study of anthropometric indices predicting lean nonalcoholic fatty liver disease
Scientific Title:Acronym Retrospective study of anthropometric indices predicting lean nonalcoholic fatty liver disease
Region
Japan

Condition
Condition nonalcoholic fatty liver disease
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate anthropometric indices predicting lean nonalcoholic fatty liver disease in Japan.
Basic objectives2 Others
Basic objectives -Others To investigate associations of body mass index and waist circumference with lean nonalcoholic fatty liver disease in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes nonalcoholic fatty liver disease
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

Not applicable
Gender Male and Female
Key inclusion criteria Participants who received abdominal ultrasound scan in health checkups at Nihon University Hospital from January 2019 to December 2019 were potentially eligible.
Key exclusion criteria Missing data or positive result of hepatitis B virus surface antigen.
Missing data or positive result of hepatitis C antibody.
Alcohol consumption; exceeding 210 g per week for men; exceeding 140 g per week for women.
Pregnancy.
Body mass index exceeding 23.
High waist circumference; exceeding 85 cm for men; exceeding 90 cm for women.
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name Midori
Middle name
Last name Fujishiro
Organization Nihon University Hospital
Division name Internal Medicine
Zip code 101-8309
Address 1-6, kandasurugadai, chiyoda-ku,Tokyo
TEL 03-3293-1711
Email fujishiro.midori@nihon-u.ac.jp

Public contact
Name of contact person
1st name Sho
Middle name
Last name Tanaka
Organization Nihon University Hospital
Division name Internal Medicine
Zip code 101-8309
Address 1-6, kandasurugadai, chiyoda-ku,Tokyo
TEL 03-3293-1711
Homepage URL
Email tanaka.sho@nihon-u.ac.jp

Sponsor
Institute Nihon University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nihon University Hospital IRB
Address 1-6, kandasurugadai, chiyoda-ku,Tokyo
Tel 03-3203-1711
Email tanaka.sho@nihon-u.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
2020 Year 04 Month 28 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 3362
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 No longer recruiting
Date of protocol fixation
2020 Year 04 Month 11 Day
Date of IRB
2020 Year 04 Month 09 Day
Anticipated trial start date
2020 Year 04 Month 11 Day
Last follow-up date
2020 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Participants who received abdominal ultrasound scan in health checkups at Nihon University Hospital from January 2019 to December 2019 were potentially eligible. Exclusion criteria includes followings; Positive for hepatitis B virus surface antigen (HBs-Ag); Positive for hepatitis C antibody (HCV-Ab); Missing data of HBs-Ag or HCV-Ab; Alcohol consumption (exceeding 210 g/week for men, exceeding 140 g/week for women); Pregnancy; Body mass index exceeding 23 kg/m2; High waist circumference (exceeding 85 cm for men, exceeding 90 cm for women). Participants were classified into two group based on the presence or absence of hepatic steatosis confirmed by abdominal ultrasound scan. Associations of body mass index, waist circumference and adult weight gain with NAFLD were investigated.

Management information
Registered date
2020 Year 04 Month 28 Day
Last modified on
2020 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045856

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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