UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000013485
Receipt No. 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 (Ver. 6)

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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
Email 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
Email akisaito@med.niigata-u.ac.jp

Sponsor
Institute Department of Applied Molecular Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015748