UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022079
Receipt No. 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

* 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 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
Email 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
Email takaomi0027@gmail.com

Sponsor
Institute Division of Periodontology, Department of Oral Function & Restoration, Graduate School of Dental Science, Kanagawa Dental University
Institute
Department

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
Email 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
URL(English) https://upload.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


Contact us.