UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between serum bilirubin level and disability in ADL in elderly patients
Title of the study (Brief title)	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	Toyoshi Inoguchi
Organization	Fukuoka City Medical Association
Division name	Fukuoka City Health Promotion Support Center
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	Toyoshi Inoguchi
Organization	Fukuoka City Medical Association
Division name	Fukuoka City Health Promotion Support Center
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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