UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014877 |
|---|---|
| Receipt number | R000016964 |
| Scientific Title | Analysis of relationship between chronic periodontitis and glucose metabolic parameters (Ehime Dental Diabetes Study) |
| Date of disclosure of the study information | 2014/08/18 |
| Last modified on | 2014/08/18 07:49:29 |
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Basic information
Public title
Analysis of relationship between chronic periodontitis and glucose metabolic parameters (Ehime Dental Diabetes Study)
Acronym
Analysis of relationship between chronic periodontitis and glucose metabolic parameters (Ehime Dental Diabetes Study)
Scientific Title
Analysis of relationship between chronic periodontitis and glucose metabolic parameters (Ehime Dental Diabetes Study)
Scientific Title:Acronym
Analysis of relationship between chronic periodontitis and glucose metabolic parameters (Ehime Dental Diabetes Study)
Region
| Japan |
Condition
Condition
Diabetes, chronic periodontitis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Oral surgery |
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Chronic periodontitis and diabetes are diseases based on inflammation. The purpose of this study is to elucidate the relationship between two diseases using glucose metabolic parameters and gene haplotypes.
Basic objectives2
Others
Basic objectives -Others
Among the patients receiving regular dental treatments, glucose metabolic parameters, including blood glucose, resistin and insulin, are examined and study the relationship between the parameters and severity of periodontitis. When approval of genomic examination is obtained, we determine haplotypes of resistin gene SNPs, and investigate its relevant to chronic periodontitis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cytokines: inflammation parameters relating diabetes and chronic periodontitis such as TNF-alpha and resistin.
Endotoxin relating substances: Lipopolysaccharide (LPS), LPS binding protein (LBP), CD14
Glucose metabolic parameters: glucose, insulin, HbA1c
Oral function: number of remaining teeth, occlusion, taste, cleanliness
Periodontitis: severity, quantification of periodontitis bacterium
Gene SNPs: diabetes, HLA
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
* Outpatients.
* Cases from whom informed consent was obtained.
* Genetic examination will be performed when informed consent, approved by the institutional review board, is obtained.
Key exclusion criteria
Cases judged inappropriate by the physician or dentist in charge.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiko Osawa |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Diabetes and Molecular Genetics
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295, Japan
TEL
089-960-5647
harosawa@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Onuma |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Diabetes and Molecular Genetics
Zip code
Address
Shitsukawa, Toon, Ehime 791-0295, Japan
TEL
089-960-5647
Homepage URL
onuma@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime Dental Diabetes Study Group
Institute
Department
Personal name
Funding Source
Organization
Ehime Dental Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Ehime University Graduate School of Medicine, Department of Oral and Maxillofacial Surgery
Name of secondary funder(s)
Ehime University Graduate School of Medicine, Department of Oral and Maxillofacial Surgery
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
愛媛Dental Diabetes研究会参加歯科医院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional method
Management information
Registered date
| 2014 | Year | 08 | Month | 18 | Day |
Last modified on
| 2014 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016964
