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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041279
Receipt No. R000047145
Scientific Title Study on the association between AGEs and sleep apnea syndrome in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2020/08/02
Last modified on 2020/08/02

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Basic information
Public title Study on the association between AGEs and sleep apnea syndrome in patients with type 2 diabetes mellitus
Acronym Study on the association between AGEs and sleep apnea syndrome in patients with type 2 diabetes mellitus
Scientific Title Study on the association between AGEs and sleep apnea syndrome in patients with type 2 diabetes mellitus
Scientific Title:Acronym Study on the association between AGEs and sleep apnea syndrome in patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition Type 2 Diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to determine the relationship between skin autofluorescence(skin AF) and clinical context and to clarify the association between skin autofluorescence and sleep apnea syndrome by measuring skin autofluorescence and performing a watch PAT in patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between skin AF and AHI measured by watch PAT.
Key secondary outcomes 1.Correlation of PSQI, ESS, NoSAS score and No-apnea score with skin AF.
2.Correlation of PSQI, ESS, NoSAS score and No-apnea score with AHI measured by watch PAT.
3.Correlation of carotid artery echocardiography, Endo PAT, ABI, baPWV, CAVI and other macrovascular diseases, body composition analysis, and microvascular diseases with skin AF.
4.Correlation of carotid artery echocardiography, Endo PAT, ABI, baPWV, CAVI and other macrovascular diseases, body composition analysis, and microvascular diseases with AHI measured by watch PAT.

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 (1) Patients with a diagnosis of type 2 diabetes at the time of obtaining consent
(2) Patients who were 20 years of age or older at the time of obtaining consent
(3) The participant himself or herself is fully informed about the research and agrees in writing.
(4) Any gender
Key exclusion criteria (1) Patients using CPAP for the diagnosis of obstructive sleep apnea syndrome
(2) After extreme sunburn
(3) Serious infections, currently being treated for a carrier cancer (can be included if the patient is in remission and being followed up), serious respiratory disease,serious trauma, serious neurological or autonomic disorders, hyperthyroidism or hypothyroidism(can be included if under treatment and under control)
(4) Type 1 diabetes patients
(5) Pregnant patients
(6) Patients on dialysis
(7) Patients with persistent non-sinus arrhythmias
(8) Patients with pacemaker implantation
(9) Patients taking an alpha-blocker
(10) Patients undergoing treatment with steroids (oral or injectable)
(11) Patients with craniofacial abnormalities.
(12) Other items deemed inappropriate by the physician in charge
(13)Patients refused to participate in the study by blanket consent
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tadashi
Middle name
Last name Yamakawa
Organization Yokohama City University Medical Center
Division name Department of endocrinology & metabolism
Zip code 232-0024
Address 4-57, Urahunecho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan
TEL 045-261-5656
Email yamakat@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Masahiro
Middle name
Last name Ichikawa
Organization Yokohama City University Medical Center
Division name Department of endocrinology & metabolism
Zip code 232-0024
Address 4-57, Urahunecho, Minami-ku, Yokohama-shi, Kanagawa, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email t196009c@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Yokohama City University Certified Institutional Review Board
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
Tel 0453707627
Email rinri@yokohama-cu.ac.jp

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 横浜市立大学附属市民総合医療センター

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 02 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 Open public recruiting
Date of protocol fixation
2020 Year 07 Month 08 Day
Date of IRB
2020 Year 07 Month 29 Day
Anticipated trial start date
2020 Year 08 Month 02 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will collect information from the medical record, including background and history, collected at the time of obtaining consent or previously from patients with type 2 diabetes who are in or outpatients. We will measure blood and skin AF. We will perform a watch PAT to assess the AHI for sleep apnea syndrome. We will evaluate other complications within the scope of practice (EKG, carotid echocardiogram, fundus examination, ABI, baPWV, CAVI, Endo pat, body composition analysis, etc.).

Management information
Registered date
2020 Year 08 Month 02 Day
Last modified on
2020 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047145

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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