UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013751 |
|---|---|
| Receipt number | R000016047 |
| Scientific Title | Study on common risk cytokine genes for periodontitis, diabetes mellitus, and rheumatoid arthritis |
| Date of disclosure of the study information | 2014/04/21 |
| Last modified on | 2017/10/19 17:11:38 |
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Basic information
Public title
Study on common risk cytokine genes for periodontitis, diabetes mellitus, and rheumatoid arthritis
Acronym
Study on common risk cytokine genes for periodontitis, diabetes mellitus, and rheumatoid arthritis
Scientific Title
Study on common risk cytokine genes for periodontitis, diabetes mellitus, and rheumatoid arthritis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiromasa Yoshie |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Periodontology
Zip code
Address
2-5274 Gakkocho-Dori, Chuo-ku, Niigata, 951-8514 Japan
TEL
025-227-2869
yoshie@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuo Kobayashi |
Organization
Niigata University Medical and Dental Hospital
Division name
General Dentistry and Clinical Education Unit
Zip code
Address
2-5274, Gakkocho-dori, Chuo-ku, Niigata, 951-8514, Japan
TEL
025-227-2870
Homepage URL
kotetsuo@dent.niigata-u.ac.jp
Sponsor or person
Institute
Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences
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
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 25 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016047
