UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006356 |
|---|---|
| Receipt number | R000007544 |
| Scientific Title | Study on the effects of periodontal treatment on metabolic control of type 2 diabetes |
| Date of disclosure of the study information | 2011/09/20 |
| Last modified on | 2013/02/18 16:26:02 |
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Basic information
Public title
Study on the effects of periodontal treatment on metabolic control of type 2 diabetes
Acronym
The effects of periodontal treatment on diabetes
Scientific Title
Study on the effects of periodontal treatment on metabolic control of type 2 diabetes
Scientific Title:Acronym
The effects of periodontal treatment on diabetes
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the effects of periodontal treatment on the changes of glycated hemoglobin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Hemoglobin A1c
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
type 2 diabetes without insulin therapy
Key exclusion criteria
acute illness
chronic fatigue disease
anti-inflammatory medication recipient
depression
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishimura, Fusanori |
Organization
Hiroshima University Graduate School of Biomedical Sciences
Division name
Department of Dental Science for Health Promotion
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553
TEL
082-257-5655
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nishimura, Fusanori |
Organization
Hiroshima University Graduate School of Biomedical Sciences
Division name
Department of Dental Science for Health Promotion
Zip code
Address
TEL
Homepage URL
fusanori@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Study
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
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
YES
Study ID_1
Epidemiology-59 (2008)
Org. issuing International ID_1
Hiroshima University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 20 | 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
Periodontal treatment resullted in improvement in hemoglobin A1c
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
| 2008 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 31 | Day |
Other
Other related information
The effects of periodontal treatment on the changes of hemoglobin A1c
Management information
Registered date
| 2011 | Year | 09 | Month | 15 | Day |
Last modified on
| 2013 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007544
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
