UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040264 |
|---|---|
| Receipt number | 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 | 2021/05/07 13:46:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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.
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
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
tanaka.sho@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
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
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
https://www.mdpi.com/2075-4418/10/11/863
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2075-4418/10/11/863
Number of participants that the trial has enrolled
3503
Results
AWG was significantly associated with NAFLD (crude OR 5.09; P<0.001 and adjusted OR, 1.81; p = 0.003). Waist circumference was significantly associated with NAFLD in both the AWG (OR, 1.24; p < 0.001) and non-AWG groups (OR, 1.17; p < 0.001). The association between body mass index and NAFLD existed in the former group (OR, 1.76; p < 0.001), but was not significant in the latter group.
Results date posted
| 2021 | Year | 05 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We retrospectively analyzed patients who underwent abdominal ultrasonography as part of the annual health checkup between January 2019 and December 2019.
Participant flow
The exclusion criteria included positive results or missing data for hepatitis B virus surface antigen and/or hepatitis C antibody, alcohol consumption (210 or more g/week for men, 140 or more g/week for women), pregnancy, BMI 23 or more kg/m2. After the exclusion, participants were classified into two groups according to the presence or absence of AWG 10 or more kg: the AWG group and the non-AWG group.
Adverse events
Not applicable because this study was completely observational.
Outcome measures
Non-alcoholic fatty liver disease (NAFLD).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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. 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
| 2021 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.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 |
