UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004775 |
|---|---|
| Receipt number | R000005686 |
| Scientific Title | The effect of periodontal care on lipid profiles in type 2 diabetic patients. |
| Date of disclosure of the study information | 2010/12/22 |
| Last modified on | 2010/12/22 14:01:49 |
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Basic information
Public title
The effect of periodontal care on lipid profiles in type 2 diabetic patients.
Acronym
The effect of periodontal care on lipid profiles in type 2 diabetic patients.
Scientific Title
The effect of periodontal care on lipid profiles in type 2 diabetic patients.
Scientific Title:Acronym
The effect of periodontal care on lipid profiles in type 2 diabetic patients.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of periodontal care on lipid metabolism via attenuation of persistent inflammation in type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
PCR(plaque control record), proinflammatory markers(hsCRP, TNFa), HbA1c,lipid profiles(TC, HDL-C, LDL-C, TG, lipoprotein fraction)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
oral care group
Interventions/Control_2
control group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
type 2 diabetic subjects, who were hospitalized at our hospital for diabetes
Key exclusion criteria
patients in whom the number of existing teeth was less than 12.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuhito Tone |
Organization
National Hospital Organization, Okayama Medical Center
Division name
Department of Diabetes and Metabolism
Zip code
Address
1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan.
TEL
+81-86-294-9911
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuhito Tone |
Organization
National Hospital Organization, Okayama Medical Center
Division name
Department of Diabetes and Metabolism
Zip code
Address
1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan.
TEL
+81-86-294-9911
Homepage URL
aitone@okayama3.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization, Okayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
国立病院機構 岡山医療センター（岡山県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 22 | Day |
Last modified on
| 2010 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005686
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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