UMIN-CTR Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Fukuoka City Health Promotion Support Center

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Yukuhasi Central Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2018

Year

01

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2017

Year

12

Month

24

Day

Last modified on

2017

Year

12

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034869