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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030542
Receipt No. R000034869
Scientific Title Relationship between serum bilirubin level and disability in ADL in elderly patients
Date of disclosure of the study information 2018/01/04
Last modified on 2017/12/30

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Basic information
Public title Relationship between serum bilirubin level and disability in ADL in elderly patients
Acronym Serum bilirubin level and disability in ADL
Scientific Title Relationship between serum bilirubin level and disability in ADL in elderly patients
Scientific Title:Acronym Serum bilirubin level and disability in ADL
Region
Japan

Condition
Condition Elderly patients (>70 years old) under treatment in hospital
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology Geriatrics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In ageing societies such as Japan and Western countries, disability in Activities of Daily Living (ADL) is a serious problem, as it results in loss of independence, extensive use of healthcare resources, admission to long-term care and death. Knowing which factors predict ADL disability is very useful in identifying elderly people who might benefit from an intervention that prevents disability or increases ability in daily life. ADL disability is an adverse outcome of frailty that is a functional status and characterized by progressive loss of reserve and adaptive capacity associated with an overall deterioration in health. Frailty is closely associated with the concurrent presence of two or more age-related chronic diseases (comorbidity) and sarcopenia. Oxidative stress may be a common pathogenic factor for both age-related chronic diseases and sarcopenia. We and
others have previously suggested that serum bilirubin level may serve as a good biomarker for systemic antioxidant capacity and subsequent age-related chronic diseases. Therefore, in this study, we cross-sectionally and longitudinally examine the relationship between decreased serum bilirubin level and disability in ADL.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes In the cross-sectional study, we will examine whether serum bilirubin level is a significant determinant for disability in ADL (transferring, eating, toileting, bathing, clothing) by multivariate analysis. Afterwards, normal ADL patients are followed periodically (1, 2, 3 years later), and as a longitudinal study, we will examine whether serum bilirubin level is a significant predictor for newly onset of disability in ADL by multivariate analysis. We will also determine the cut-off value of serum bilirubin level.
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
70 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Elderly patients with chronic diseases treated in Yukuhashi Central Hospital
Key exclusion criteria Those who suffer from hepatobiliary diseases and hemolytic anemia.
Those who suffer from active malignant diseases.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyoshi Inoguchi
Organization Fukuoka City Medical Association
Division name Fukuoka City Health Promotion Support Center
Zip code
Address Maizuru 2-5-1, Chuou-ku, Fukuoka city, 810-0073
TEL 81-92-751-7778
Email toyoshi.inoguchi@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Toyoshi Inoguchi
Organization Fukuoka City Medical Association
Division name Fukuoka City Health Promotion Support Center
Zip code
Address Maizuru 2-5-1, Chuou-ku, Fukuoka city, 810-0073
TEL 81-92-751-7778
Homepage URL
Email toyoshi.inoguchi@gmail.com

Sponsor
Institute Fukuoka City Health Promotion Support Center
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Yukuhasi Central Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人森和会行橋中央病院(福岡県)
福岡市健康づくりサポートセンター(福岡県)


Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 04 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
2017 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In the cross-sectional study, we will examine whether serum bilirubin level is a significant determinant for disability in ADL (transferring, eating, toileting, bathing, clothing) by multivariate analysis. Afterwards, normal ADL patients are followed periodically (1, 2, 3 years later), and as a longitudinal study, we will examine whether serum bilirubin level is a significant predictor for newly onset of disability in ADL by multivariate analysis. We will also determine the cut-off value of serum bilirubin level.

Management information
Registered date
2017 Year 12 Month 24 Day
Last modified on
2017 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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