UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on common risk cytokine genes for periodontitis, diabetes mellitus, and rheumatoid arthritis
Title of the study (Brief title)	Study on common risk cytokine genes for periodontitis, diabetes mellitus, and rheumatoid arthritis
Region	Japan

Condition
Condition	Periodontitis, Diabetes mellitus, Rheumatoid arthritis
Classification by specialty	Endocrinology and Metabolism Clinical immunology Dental medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	The aim of the present study is to identify common risk cytokine genes for periodontitis, diabetes mellitus, and rheumatoid arthritis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Genotype and allele frequencies of cytokines and their related molecules
Key secondary outcomes	Clinical and blood data on systemic and periodontal diseases

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	30 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Individuals with periodontitis, diabetes mellitus, and rheumatoid arthritis 2. Individuals with 30 years or older and written informed consent. 3. Individuals with a minimum of 15 teeth.
Key exclusion criteria	1. Individuals with severe systemic diseases 2. Individuals who are considered not eligible for the present study due to any reasons by the investigators.
Target sample size	800

Research contact person
Name of lead principal investigator	Hiromasa Yoshie
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Division of Periodontology
Address	2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL	025-227-2869
Email	yoshie@dent.niigata-u.ac.jp

Public contact
Name of contact person	Tetsuo Kobayashi
Organization	Niigata University Medical and Dental Hospital
Division name	General Dentistry and Clinical Education Unit
Address	2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL	025-227-2870
Homepage URL
Email	kotetsuo@dent.niigata-u.ac.jp

Sponsor
Institute	Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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)

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	新潟大学歯学部（新潟県）、新潟県立リウマチセンター（新潟県）、愛知学院大学歯学部（愛知県）、岡山大学歯学部（岡山県）、徳島大学歯学部（徳島県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 25 Day
Anticipated trial start date	2013 Year 10 Month 30 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 04 Month 30 Day
Date analysis concluded	2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	A total of 17 candidate single nucleotide polymorphisms were assessed in 185 patients with RA and chronic periodontitis (CP), 149 patients with type 2 DM and CP, 251 patients with CP, and 130 systemically and periodontally healthy controls from a cohort of Japanese adults. The results indicated that the potassium voltage-gated channel KQT-like subfamily, member 1 (KCNQ1) rs2237892 and the peptidylarginine deiminase type 4 (PADI4)_104 rs1748033 polymorphisms were significantly associated with the comorbidity of RA and CP. Additionally, a trend toward increase was shown in the serum levels of anti-cyclic citrullinated peptide immunoglobulin G in the patients with RA and CP as compared to those with RA only. These results suggest that the KCNQ1 and possibly the PADI4_104 may constitute a shared risk gene for RA and CP in Japanese adults.
Other related information	The present research only consists of the patients who exhibit periodontitis, diabetes mellitus, and rheumatoid arthritis, without acute inflammation.

Management information
Registered date	2014 Year 04 Month 17 Day
Last modified on	2017 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016047