![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||||
Condition | nonalcoholic fatty liver disease | |||
Classification by specialty |
|
|||
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
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 |
|
||||||
Last modified on |
|
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 |