UMIN-CTR Clinical Trial

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
Institute	Toho University School of Medicine
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022354