UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014585 |
|---|---|
| Receipt number | R000016554 |
| Scientific Title | Effect of Periodontal Treatment on Glucose Metabolism among middle-aged men and women (Randamized Controled Trial) |
| Date of disclosure of the study information | 2014/07/17 |
| Last modified on | 2016/07/19 14:16:09 |
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Basic information
Public title
Effect of Periodontal Treatment on Glucose Metabolism among middle-aged men and women (Randamized Controled Trial)
Acronym
Effect of Periodontal Treatment on Glucose Metabolism
Scientific Title
Effect of Periodontal Treatment on Glucose Metabolism among middle-aged men and women (Randamized Controled Trial)
Scientific Title:Acronym
Effect of Periodontal Treatment on Glucose Metabolism
Region
| Japan |
Condition
Condition
Borderline diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the impact of periodontal treatment on impaired glucose tolerance using a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HOMA-IR
Matsuda Index
Key secondary outcomes
Bleeding on probing
Mean pocket depth
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Periodontal treatment ->
no treatment
Interventions/Control_2
no treatment ->
Periodontal 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
| 30 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Borderline diabetes
(Participants without normal and Diabetes mellitus)
Key exclusion criteria
Normal(Fasting blood glucose level <110mg/dl and 2-hours75g oral glucose tolerance test(OGTT)<140 mg/dl)
Diabetes mellitus(Fasting blood glucose level>=126mg/dl or 2-hours75gOGTT>=200 mg/dl)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Isao Saito |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Basic Nursing and Health Science
Zip code
Address
Shitsukawa,Toon,Ehime
TEL
089-960-5403
saitoi@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Saito |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Basic Nursing and Health Science
Zip code
Address
Shitsukawa,Toon,Ehime
TEL
089-960-5403
Homepage URL
saitoi@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 17 | 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
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
| 2011 | Year | 08 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 17 | Day |
Last modified on
| 2016 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016554
| 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 |
