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
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
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
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
