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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025335
Receipt No. 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 2016/12/20

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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
Last name of lead principal investigator
1st name
Middle name
Last name Katsunori Ikewaki
Organization National defense medical college
Division name Division of anti-aging, and vascular medicine
Zip code
Address 3-2 Namiki Tokorozawa Saitama
TEL 0429-95-1211
Email kikewaki@hotmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Katsunori Ikewaki
Organization National defense medical college
Division name Division of anti-aging, and vascular medicine
Zip code
Address 3-2 Namiki Tokorozawa Saitama
TEL 0429-95-1211
Homepage URL
Email kikewaki@hotmail.com

Sponsor
Institute National Defense Medical College
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 04 Day
Last follow-up date
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
2016 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029149

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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