UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013485 |
|---|---|
| Receipt number | R000015748 |
| Scientific Title | Prospective observational study of the relationship between periodontal disease and lifestyle-related disease monitored by atherosclerosis-related biomarkers |
| Date of disclosure of the study information | 2014/03/23 |
| Last modified on | 2019/10/02 15:03:26 |
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Basic information
Public title
Prospective observational study of the relationship between periodontal disease and lifestyle-related disease monitored by atherosclerosis-related biomarkers
Acronym
Prospective observational study of the relationship between periodontal disease and lifestyle-related disease monitored by atherosclerosis-related biomarkers
Scientific Title
Prospective observational study of the relationship between periodontal disease and lifestyle-related disease monitored by atherosclerosis-related biomarkers
Scientific Title:Acronym
Prospective observational study of the relationship between periodontal disease and lifestyle-related disease monitored by atherosclerosis-related biomarkers
Region
| Japan |
Condition
Condition
Periodontal disease
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
| Infectious disease | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between periodontal disease and lifestyle-related disease such as diabetes mellitus, dyslipidemia, and hypertension or atherosclerosis by monitoring related biomarkers
Basic objectives2
Others
Basic objectives -Others
Relationship between periodontal disease and lifestyle-related disease or atherosclerosis-related biomarkers
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cross-sectional evaluation of the relationship between clinical parameters of periodontitis and incidence of lifestyle-related disease (diabetes mellitus, dyslipidemia, and hypertension) or atherosclerosis
Key secondary outcomes
1) Analysis of biomarkers and laboratory parameters related to diabetes mellitus, dyslipidemia, hypertension and atherosclerosis
Serum markers
hsCRP
IL-6
TNF-alpha
oxidized LDL
Remnant
small dense LDL
HDL2 (HDL3)
Adiponectin
Myeloperoxidase (MPO)
Podocalyxin
Proproteinconvertase subtilisin/kexin type 9
Antibody against periodontopathic bacteria
Urinary markers
Megalin
Podocalyxin
Alpha1MG
Beta2MG
N-acetyl-beta-D-glucosaminidase (NAG)
Albumin
Neutrophil gelatinase-associated lipocalin (NGAL)
L-type fatty acid binding protein (L-FABP)
etc.
2) Intestinal flora
Meta 16S rRNA gene analysis
3) PWV/ABI
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
Those who have given written informed consent on the use of their data for the study
Key exclusion criteria
Those who are considered not eligible for the study by attending doctors due to any medical reasons
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Saito |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Applied Molecular Medicine
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL
025-227-0915
akisaito@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Saito |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Applied Molecular Medicine
Zip code
951-8510
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
TEL
025-227-0915
Homepage URL
akisaito@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
DENKA SEIKEN Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology
IRB Contact (For public release)
Organization
Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata-shi
Tel
025-227-0915
akisaito@med.niigata-u.ac.jp
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
コープケミカル株式会社(新潟県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/jre.12533
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/jre.12533
Number of participants that the trial has enrolled
131
Results
In conclusion, serum PCSK9 and TBIL were identified as potential biomarkers correlated with periodontal parameters. Serum PCSK9 could be a candidate biomarker in the diagnosis of chronic periodontitis with potential ability to evaluate the risk of periodontitis to alter the concentration of serum lipids, and thus promote ASVD.
Results date posted
| 2019 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study cohort included a total of 131 industrial employees (119 male subjects, 12 female subjects) who underwent annual health examinations in Niigata City, Japan.
Participant flow
A total of 108 male subjects were finally included for analysis after subjects with fewer than 15 teeth and women (because of the small number of female subjects) were excluded to avoid potential bias.
Adverse events
none
Outcome measures
(Serum markers)
hsCRP
IL-6
TNF-a
oxidized LDL
Remnant
small dense LDL
HDL2, HDL3
Adiponectin
Myeloperoxidase (MPO)
Podocalyxin
Proproteinconvertase subtilisin/kexin type 9
Antibody against periodontopathic bacteria
(Urinary markers)
Megalin
Podocalyxin
a1MG
b2MG
N-acetyl-B-D-glucosaminidase (NAG)
Albumin
Neutrophil gelatinase-associated lipocalin (NGAL)
L-type fatty acid binding protein (L-FABP)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Relationship between clinical parameters of periodontitis and incidence of lifestyle-related disease (diabetes mellitus, dyslipidemia, and hypertension) or atherosclerosis
Management information
Registered date
| 2014 | Year | 03 | Month | 23 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015748
| Research Plan | |
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| Registered date | File name |
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