UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022079 |
|---|---|
| Receipt number | R000021198 |
| Scientific Title | A study on the relationship between nonalcoholic fatty liver disease and periodontal disease, and on the effect of periodontaldisease on nonalcoholic fatty liver disease |
| Date of disclosure of the study information | 2016/04/27 |
| Last modified on | 2019/05/06 22:43:44 |
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Basic information
Public title
A study on the relationship between nonalcoholic fatty liver disease and periodontal disease, and on the effect of periodontaldisease on nonalcoholic fatty liver disease
Acronym
A study on the relevance of nonalcoholic fatty liver disease and periodontal disease
Scientific Title
A study on the relationship between nonalcoholic fatty liver disease and periodontal disease, and on the effect of periodontaldisease on nonalcoholic fatty liver disease
Scientific Title:Acronym
A study on the relevance of nonalcoholic fatty liver disease and periodontal 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
NO
Objectives
Narrative objectives1
1, To investigate the periodontal disease morbidity situation in NAFLD patients(Prospective, cross sectional observational study).
2, To investigate the effect of periodontal treatment on NAFLD patient(Medical investigator initiated, multiple center, prospective, randomized controlled study).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1, To investigate the periodontal disease morbidity situation in NAFLD patients(Prospective, cross sectional observational study).
-medical interview, oral findings, blood findings, findings of periodontal disease bacteria in saliva and serum, image findings
2, To investigate the effect of periodontal treatment on NAFLD patient(Medical investigator initiated, multiple center, prospective, randomized controlled study).
-Change from baseline in ALT at Week 12
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
periodontal treatment
Interventions/Control_2
No treatment
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, Inclusion criteria of observational study.
1) Patients aged between 20 years and 85 years (both inclusive) at the time of informed consent.
2) Patients with NAFLD which did not respond to 3-month diet and exercise therapy.
3) Patients who are able to provide written consent to participate in this research in person, follow instructions during participation in this research, and undergo protocol-specified physical examination and other examinations, and report symptoms or events.
4) Patients with a diagnosis of fatty liver based on abdominal ultrasonography, TE or MRI.
5) Patients with no habitual alcohol consumption (i.e., consumption of ethanol less than 30 g/day in men and less than 20 g/day in women).
2, inclusion criteria of intervention study.
1) Patients aged between 20 years and 85 years (both inclusive) at the time of informed consent.
2) Patients with NAFLD which did not respond to 3-month diet and exercise therapy.
3) Patients who are able to provide written consent to participate in this research in person, follow instructions during participation in this research, and undergo protocol-specified physical examination and other examinations, and report symptoms or events.
4) Patients with an ALT level of more than 40 IU/L at the start of this study.
5) Patients with a diagnosis of fatty liver based on abdominal ultrasonography, TE or MRI.
6) Patients with F1, F2, or F3 fibrosis or equivalent on TE (FibroScan) or MRE
7) Patients with no habitual alcohol consumption (i.e., consumption of ethanol less than 30 g/day in men and less than 20 g/day in women).
8) Periodontal disease patient.
Key exclusion criteria
2, Exclusion criteria of observational study.
1) Patients with any change to their oral medications within 3 months before informed consent
2) Patients with any other concurrent liver disease, such as hepatitis C, hepatitis B, or autoimmune hepatitis
3) Patients with concurrent or past history of any serious cardiac, vascular, hematological, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatry disease
4) Patients with drug-induced, symptomatic NAFLD
5) Other patients who are inappropriate as participants in this research in the opinion of the principal investigator etc.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Minabe |
Organization
Graduate School of Dental Science, Kanagawa Dental University
Division name
Division of Periodontology, Department of Oral Function & Restoration
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka , Kanagawa 238-8580, Japan.
TEL
046-822-8855
minabe@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
Yokohama City University Graduate School of Medicine,
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan.
TEL
045-787-2640
Homepage URL
takaomi0027@gmail.com
Sponsor or person
Institute
Division of Periodontology, Department of Oral Function & Restoration, Graduate School of Dental Science, Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of gastroenterology and hepatology, Yokohama city university
Kanagawa dental university, Yokohama clinic
Department of Pathophysiology, Okayama university
Iwasaki internal medicine clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawa Dental University
Address
82 Inaoka-cho, Yokosuka , Kanagawa 238-8580, Japan.
Tel
046-822-8751
gakuchou@kdu.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
| 2016 | Year | 04 | Month | 27 | 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
40
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
| 2015 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
According to experimental protocol, we perform a prospective observational study in conjunction with periodontal disease for NAFLD patients before an intervention examination.
Management information
Registered date
| 2016 | Year | 04 | Month | 26 | Day |
Last modified on
| 2019 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021198
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/06/10 | UMIN000022079研究計画書_TK1.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
