UMIN-CTR Clinical Trial

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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