UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019329
Receipt number R000022354
Scientific Title Examination of the association between type 2 diabetes and sleep disorder by the questionnaire about sleep disorder.
Date of disclosure of the study information 2015/10/13
Last modified on 2022/10/24 22:20:14

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Basic information

Public title

Examination of the association between type 2 diabetes and sleep disorder by the questionnaire about sleep disorder.

Acronym

Examination of the association between type 2 diabetes and sleep disorder by the questionnaire about sleep disorder.

Scientific Title

Examination of the association between type 2 diabetes and sleep disorder by the questionnaire about sleep disorder.

Scientific Title:Acronym

Examination of the association between type 2 diabetes and sleep disorder by the questionnaire about sleep disorder.

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For type 2 diabetes patients visiting this hospital,we carry out questionnaires about the sleep. It is intended to grasp a ratio and a kind of a sleep disorder in the type 2 diabetes patients,and consider relations between glucose tolerance and a sleep disorder.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Score of the Pittsburgh Sleep Quality Index

Key secondary outcomes

Score of the Eveningness Questionnaire
Score of the sleep disorder screening
HbA1c and fasting blood glucose
Affection period of diabetes
lipid parameters(HDL cholesterol,LDL cholesterol,triglyceride)
body weight,blood pressure,and abdominal circumscription


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Type 2 diabetes patients
(2)Adalts who are 20 years or older and 80 years or younger.
(3) Patients who can understand consent brief and other explanation documents having the ability of the agreement about participation in this examination
*We take it as an agreement by the collection of the questionnaire which was filled in.

Key exclusion criteria

(1) Type 1 diabetes mellitus patients or secondary diabetic mellitus
(2) The patient who has taken a sleeping drug or an antipsychotic drug
(3) In addition, the patients who will be judged inappropriate by an attendant physician

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Takahisa
Middle name
Last name Hirose

Organization

Toho University School of Medicine

Division name

Divsion of diabetes, metabolism and endocrinology

Zip code

143-8541

Address

6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan

TEL

0337624151

Email

takahisa.hirose@med.toho-u.ac.jp


Public contact

Name of contact person

1st name Takahisa
Middle name
Last name Hirose

Organization

Toho University School of Medicine

Division name

Divsion of diabetes, metabolism and endocrinology

Zip code

143-8541

Address

6-11-1 Omori-nishi,Ota-ku,Tokyo 143-8541,Japan

TEL

0337624151

Homepage URL


Email

takahisa.hirose@med.toho-u.ac.jp


Sponsor or person

Institute

Toho University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Toho University School of Medicine

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

ethics committee of Toho University school if medicine

Address

6-11-1 Omori-nashi, Ota-Ku, Tokyo 143-8541, Japan

Tel

0337624151

Email

oomori.rinri@ex.toho-u.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



Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 13 Day


Related information

URL releasing protocol

DOI: 10.1007/s13340-021-00516-3

Publication of results

Published


Result

URL related to results and publications

DOI: 10.1007/s13340-021-00516-3

Number of participants that the trial has enrolled

472

Results

Younger T2DM patients had poorer sleep quality and higher BMI.

Results date posted

2022 Year 10 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Type 2 diabetes who were attended our department without any symptoms of obstructive sleep apnea and any use of hypnotics.

Participant flow

A total of 472 returned the filled questionnaire. Participants who answered insufficiently (n = 66) or met the exclusion criteria (n = 26) were excluded from the analysis. Consequently, the final number of eligible participants was 380.Participants were categorized by age into four groups according to patients who were (1) less than 50 years (< 50), (2) between 50 and 60 years, (3) between 60 and 70 years, and (4) between 70 and 80 years.

Adverse events

Not applicable as this is a cohort study.

Outcome measures

Comparison of the score of Pittsburgh Sleep Quality Index and the Morning-Evening Questionnaire, Glucose metabolism-related index, anthropometric data between 4 groups.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 09 Month 28 Day

Date of IRB

2015 Year 09 Month 28 Day

Anticipated trial start date

2015 Year 10 Month 14 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design:cohort study
Recruitment of target people: Type 2 diabetes patients who consulted our facilities in from October 2015 through March 2016


Management information

Registered date

2015 Year 10 Month 13 Day

Last modified on

2022 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022354


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name