UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041279
Receipt number 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 2023/02/08 15:40:03

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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 or person

Institute

Yokohama City University Medical Center

Institute

Department

Personal name



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

Completed

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

2023 Year 02 Month 08 Day



Link to view the page

Value
https://center6.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