UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007112 |
|---|---|
| Receipt number | R000008379 |
| Scientific Title | Evaluation of relationships between hepatic steatosis and sleep apnea in subjects suspected to have abdominal obesity, and effects of CPAP treatment on hepatic steatosis. |
| Date of disclosure of the study information | 2012/01/21 |
| Last modified on | 2014/09/03 20:00:48 |
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Basic information
Public title
Evaluation of relationships between hepatic steatosis and sleep apnea in subjects suspected to have abdominal obesity, and effects of CPAP treatment on hepatic steatosis.
Acronym
Hepatic steatosis, sleep apnea and effects of CPAP therapy.
Scientific Title
Evaluation of relationships between hepatic steatosis and sleep apnea in subjects suspected to have abdominal obesity, and effects of CPAP treatment on hepatic steatosis.
Scientific Title:Acronym
Hepatic steatosis, sleep apnea and effects of CPAP therapy.
Region
| Japan |
Condition
Condition
obstructive sleep apnea, hepatic steatosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pneumology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hypothesis: Sleep apnea influences hepatic steatosis. CPAP therapy for sleep apnea improves hepatic steatosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CT attenuation of liver
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CPAP (Continuous Positive Airway Pressure)
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
Key inclusion criteria
(1) Evaluation of relationships between hepatic steatosis and sleep apnea
# Those who underwent polysomnography for suspicion of sleep apnea, and underwent abdominal CT at the time of polysomnography or before the introduction of CPAP (The target sample size is 200).
(2) Evaluation of effects of CPAP on hepatic steatosis
# Those who were introduced CPAP therapy for diagnosis of obstructive sleep apnea by the polysomnography described above.
# Those who were diagnosed to have abdominal obesity at the baseline evaluation.
# Six months or more elapsed from the introduction of CPAP.
Key exclusion criteria
# Those who have positive serological HBs antigen, positive serological HCV antibody, or liver disease other than fatty liver.
# Those who have other serious complications.
# Those whose blood BNP levels are 100pg/ml or more.
# Those who take drugs which may cause of hepatic steatosis (amiodarone, methotrexate, systemic steroids, etc.)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Chin |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
Address
Shogoin 54, Kawahara-cho, Sakyo-Ku, Kyoto, Japan
TEL
075-751-3852
chink@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiro Toyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Care and Sleep Control Medicine
Zip code
Address
Shogoin 54, Kawahara-cho, Sakyo-Ku, Kyoto, Japan
TEL
075-751-3852
Homepage URL
ytoyama@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of respiratory medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine, Department of Respiratory Care and Sleep Control Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 21 | Day |
Last modified on
| 2014 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008379
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
