UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038530 |
|---|---|
| Receipt number | R000043289 |
| Scientific Title | Influence of physical activity for improvement of hepatic inflammation in patients with nonalcoholic fatty liver disease |
| Date of disclosure of the study information | 2019/11/11 |
| Last modified on | 2021/06/08 12:09:33 |
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Basic information
Public title
Influence of physical activity for improvement of hepatic inflammation in patients with nonalcoholic fatty liver disease
Acronym
Influence of physical activity in patients with nonalcoholic fatty liver disease
Scientific Title
Influence of physical activity for improvement of hepatic inflammation in patients with nonalcoholic fatty liver disease
Scientific Title:Acronym
Influence of physical activity in patients with 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
Non-alcoholic fatty liver disease (NAFLD) is a risk factor for liver cancer. Dietary and exercise therapy is recommended to prevent NAFLD. However, few reports have investigated the effects of physical activity on NAFLD. The purpose of this study is to investigate the effect of PA on inflammation of the liver of patients with NAFLD after paying attention to obesity closely related to NAFLD.
Basic objectives2
Others
Basic objectives -Others
Observational research
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
blood biochemical test(AST, ALT, LDH,ALP,T-Bil, TC, TG).
Key secondary outcomes
Amount of physical activity, Body weight, body composition(skeletal muscle mass, body fat mass). Total energy intake,smoking habit.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patient diagnosed as nonalcoholic fatty liver disease: NAFLD
2. Informed Consent has been obtained in writing form.by himself / herself about examination participation
Key exclusion criteria
1. Patient who has been infected with hepatitis virus
2. Patient has a clear drinking history (Alcohol amount: over 20 g / day)
3. patient who has difficulties in doing exercise, such as any joint pain, kidney dysfunction or heart disease
4. Patient who was judged as inappropriate for this research by researcher(mental disorder, etc).
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Fuminari |
| Middle name | |
| Last name | Asada |
Organization
Osaka Rosai Hospital
Division name
Research Center for the Promotion of Health and Employment Support
Zip code
591-8025
Address
3-1179,Nagasone-Cho, Kita-Ku, Sakai-City, Osaka 591-8025, Japan
TEL
072-255-7520(4255)
f-asada@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Fuminari |
| Middle name | |
| Last name | Asada |
Organization
Osaka Rosai Hospital
Division name
Research Center for the Promotion of Health and Employment Support
Zip code
591-8025
Address
3-1179,Nagasone-Cho, Kita-Ku, Sakai-City, Osaka 591-8025, Japan
TEL
072-255-7520
Homepage URL
f-asada@osakah.johas.go.jp
Sponsor or person
Institute
Japan Organization of Occupational Health and Safety
Institute
Department
Personal name
Funding Source
Organization
Japan Organization of Occupational Health and Safety
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
Osaka Rosai Hospital
Address
3-1179,Nagasone-Cho, Kita-Ku, Sakai-City, Osaka 591-8025, Japan
Tel
072-255-7520
f-asada@osakah.johas.go.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
大阪労災病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
https://environhealthprevmed.biomedcentral.com/articles/10.1186/s12199-020-00857-6
Publication of results
Published
Result
URL related to results and publications
https://environhealthprevmed.biomedcentral.com/articles/10.1186/s12199-020-00857-6
Number of participants that the trial has enrolled
45
Results
There were no significant changes in all blood and biochemical parameters in the PA non-increase group at the time of follow-up when compared with baseline levels. In the PA increase group, aspartate aminotransferase, alanine aminotransferase, and guanosine triphosphate levels were all significantly lower at follow-up than they were at baseline. Body weight did not change significantly from baseline to follow-up in both groups.
Results date posted
| 2021 | Year | 06 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 154 patients aged 20-85 years who attended the outpatient clinic of the Department of Gastroenterology, Osaka Rosai Hospital; could independently perform activities of daily living; and were given no exercise restrictions by their doctors.
Participant flow
The study included 45 patients with NAFLD who underwent follow-up examinations at least 6 months but no later than 1 year after their baseline examinations. The patients were interviewed about their daily activities and exercise habits to determine whether they had engaged in at least 3 METs per day during the previous 6 months; the quantity of PA, expressed in Ex units, was calculated as METs multiplied by hours. Patients who had achieved at least a 1-Ex increase in PA per week compared to baseline at the time of their follow-up interview the PA increase group were compared to those whose PA was the same or lower at the time of follow up the PA non increase group.
Adverse events
non
Outcome measures
Labo data, physical activity, physical function, habitual behaviors
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preventive medicine model project.
https://www.johas.go.jp/yobomodel//tabid/987/Default.aspx
Management information
Registered date
| 2019 | Year | 11 | Month | 10 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043289
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