UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002998 |
|---|---|
| Receipt number | R000003635 |
| Scientific Title | endocrine-metabolic disease and sleep apnea syndrome study |
| Date of disclosure of the study information | 2010/08/09 |
| Last modified on | 2012/10/23 09:13:51 |
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Basic information
Public title
endocrine-metabolic disease and sleep apnea syndrome study
Acronym
Endocrine-Metabolic disease and Sleep apnea syndrome Study
Scientific Title
endocrine-metabolic disease and sleep apnea syndrome study
Scientific Title:Acronym
Endocrine-Metabolic disease and Sleep apnea syndrome Study
Region
| Japan |
Condition
Condition
endocrine-metabolic disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the prevalence and severity of sleep apnea syndrome, and moreover the relathionship between them and each parameter in patients with endocrine-metabolic disease
Basic objectives2
Others
Basic objectives -Others
We aim to clarify the assocication between the change in each hormone and sleep.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the prevarence and severity of sleep apnea syndrome in patients with endocrine-metabolic disease
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with endocrine-metabolic disease (diabetes, acromegaly and Cushing disase), and the study was approved by the human ethics committee of Osaka University and a written informed consent was obtained from eac subject.
Key exclusion criteria
Subjects under domiciliary oxygen therapy and/or nasal CPAP therapy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iichiro Shimomura |
Organization
Osaka University
Division name
Metabolic medicine
Zip code
Address
2-2 B5, Yamada-oka, Suita, Osaka 565-0871, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University
Division name
Metabolic medicine
Zip code
Address
TEL
Homepage URL
kkishida@imed2.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
TEIJIN PHARMA LIMITED
Name of secondary funder(s)
TEIJIN PHARMA LIMITED
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
大阪大学医学部附属病院(大阪府)および共同研究施設
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 08 | Month | 09 | 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
Completed
Date of protocol fixation
| 2008 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 03 | Month | 31 | Day |
Other
Other related information
This study consists of prospective study.
Management information
Registered date
| 2010 | Year | 01 | Month | 08 | Day |
Last modified on
| 2012 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003635
