UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030542 |
|---|---|
| Receipt number | 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 11:46:59 |
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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
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
toyoshi.inoguchi@gmail.com
Sponsor or person
Institute
Fukuoka City Health Promotion Support Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034869
