UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055329 |
|---|---|
| Receipt number | R000063226 |
| Scientific Title | Research on nutrirional status, body composition, physical function and periodontal disease in non-alcoholic fatty liver disease. |
| Date of disclosure of the study information | 2024/08/26 |
| Last modified on | 2024/08/24 15:47:24 |
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Basic information
Public title
Research on nutrirional status, body composition, physical function and periodontal disease in non-alcoholic fatty liver disease.
Acronym
Research on nutrirional status, body composition, physical function and periodontal disease in non-alcoholic fatty liver disease.
Scientific Title
Research on nutrirional status, body composition, physical function and periodontal disease in non-alcoholic fatty liver disease.
Scientific Title:Acronym
Research on nutrirional status, body composition, physical function and periodontal disease in non-alcoholic fatty liver disease.
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease / periodontal disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The study will investigate the relationship between NAFLD and periodontal disease in patients with NAFLD by evaluating NAFLD susceptibility gene polymorphisms, nutritional pathology, obesity, sarcopenia, physical function, etc., with liver fibrosis as the primary endpoint.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver fibrosis ( Fast score, M2BPGi )
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
1. Age 20 or older at the time of obtaining consent.
2. A patient currently visting our hospital's lifestyle related liver disease outpatient clinic.
3. Patient diagnoses with fatty liver by abdominal ultrasound or CT.
4. No alcohol consumption ( alcohol consumption, calculated ethanol, is 20g or less per day for men and 20g or less per day for women ).
Key exclusion criteria
1. Patients with other hepatitis such as type B, type C, autoimmune, alcoholic, or drug-induced hepatitis.
2. Patients with a history of treatment for gastrointestinal malignant tumors.
3. Patients who are breastfeeding or possibly pregnant.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Uchida |
| Middle name | |
| Last name | Fumihiko |
Organization
Institute of Medicine, University of Tsukuba
Division name
Department of Oral and Maxillofacial Surgery
Zip code
305-8575
Address
1-1-1, tennodai, Tsukuba, Ibaraki
TEL
029-853-3870
f-uchida@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Uchida |
| Middle name | |
| Last name | Fumihiko |
Organization
Institute of Medicine, University of Tsukuba
Division name
Department of Oral and Maxillofacial Surgery
Zip code
305-8575
Address
1-1-1, tennodai, Tsukuba, Ibaraki
TEL
029-853-3870
Homepage URL
f-uchida@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Oral and Maxillofacial Surgery, Institute of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research & Development Organization
Address
2-1-1, amakubo, Tsukuba, Ibaraki
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
| 2024 | Year | 08 | Month | 26 | 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
200
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
| 2021 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study will target NAFLD and non-NAFLD patients and analyze periodontal disease, nutriental atatus, obesity, sarcopenia, body composition, etc., with liver pathology as the primary endpoint, targeting NAFLd and non-NAFLd patients. Secondary endopoints are sa follows:
Periodontal disease test values, serum IgG antibody titers against periodontal pathogenic bacteria, salivary bacterial flora analysis, presence or absence of PNPLA3 gene polymorphism, body composition ( height, weight, BMI, skeletal muscle mass, visceral fat area, etc.), blood test values ( AST, ALT, platelet count, albumin, CRP, ferritin, insulin, LDL cholesterol, HDL cholesterol, etc.), liver fat content, liver stiffness
Management information
Registered date
| 2024 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063226
