UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025335 |
|---|---|
| Receipt number | R000029149 |
| Scientific Title | Evaluation of HDL functions in patients with sleep apnea syndrome |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2019/12/23 15:17:38 |
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Basic information
Public title
Evaluation of HDL functions in patients with sleep apnea syndrome
Acronym
HDL functions in SAS patients
Scientific Title
Evaluation of HDL functions in patients with sleep apnea syndrome
Scientific Title:Acronym
HDL functions in SAS patients
Region
| Japan |
Condition
Condition
Sleep apnea syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sleep apnea syndrome (SAS) is characterized by pauses in breathing or periods of shallow breathing during sleep and associated with obesity, male gender, aging. In particular, comorbidity of obesity lead to metabolic syndrome, whereby increasing risk for cardiovascular disease (CVD). The increased risk for CVD is due to increased oxidative stress, inflammation, sympathomimetic tone, and blood pressure, together with insulin resistant. Dyslipidemia is one of major risk factors for CVD and impaired HDL function has been recently shown to be associated with CVD. In the present study, we aimed to assess HDL functions in patients with SAS
Basic objectives2
Others
Basic objectives -Others
compare various HDL functions between SAS patients and healthy controls
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
HDL functions
Key secondary outcomes
lipids, apoproteins
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
AHI 15 or greater
Key exclusion criteria
1) HbA1c >10%
2) recent cerebrovascular events (6 months)
3) liver dysfunction (AST/ALT greater than 3 fold of upper normal limits)
4) advanced renal inssuficiency including hemodialysis
5) heart failure (NYHA III/IV)
6) cancer or critically ill patients
7) pregnant women
8) serious infection
9) subjects to whom attending doctor judges inappropriate to join the study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Ikewaki |
Organization
National defense medical college
Division name
Division of anti-aging, and vascular medicine
Zip code
359-8513
Address
3-2 Namiki Tokorozawa Saitama
TEL
0429-95-1211
kikewaki@hotmail.com
Public contact
Name of contact person
| 1st name | Katsunori |
| Middle name | |
| Last name | Ikewaki |
Organization
National defense medical college
Division name
Division of anti-aging, and vascular medicine
Zip code
359-8513
Address
3-2 Namiki Tokorozawa Saitama
TEL
0429-95-1211
Homepage URL
kikewaki@hotmail.com
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National defense medical college
Address
3-2 Namiki Tokorozawa Saitama
Tel
0429-95-1211
kikewaki@hotmail.com
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
防衛医科大学校(埼玉県) 抗加齢血管内科、耳鼻咽喉科学講座
睡眠総合ケアクリニック代々木(東京都)
Other administrative information
Date of disclosure of the study information
| 2019 | 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
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case control study
case SAS patients n=80
controls non-SAS n=60
Management information
Registered date
| 2016 | Year | 12 | Month | 20 | Day |
Last modified on
| 2019 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029149
