UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007626 |
|---|---|
| Receipt number | R000008812 |
| Scientific Title | Effects of cognitive behavioral therapy for insomnia to the quality of sleep, sugar metabolism and insulin resistance among diabetes pattients |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2012/03/31 07:39:50 |
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Basic information
Public title
Effects of cognitive behavioral therapy for insomnia to the quality of sleep, sugar metabolism and insulin resistance among diabetes pattients
Acronym
Effects of cognitive behavioral therapy for insomnia among diabetes patients
Scientific Title
Effects of cognitive behavioral therapy for insomnia to the quality of sleep, sugar metabolism and insulin resistance among diabetes pattients
Scientific Title:Acronym
Effects of cognitive behavioral therapy for insomnia among diabetes patients
Region
| Japan |
Condition
Condition
diabetes, sleep disorder
Classification by specialty
| Endocrinology and Metabolism | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This object is
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c
insulin resistance
Key secondary outcomes
activity of the automous nervous system in the sleep time
subjective evaluation of sleep
mental health
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
cognitive behavioral therapy for insomnia for 3 months
Interventions/Control_2
No
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.type2 Diabetes,30-75 years old, men and women
2.Athene sleep disorder questionnaire >=4
3.range of HbAic <=1% (3 months)
4.outpatients
5.patients who have signed an agreement paper
Key exclusion criteria
1.diabetic nehropathy stage 5,diabetic gangrene
2.operation
3.Sleep apnea syndrome, leg less syndrome
4.language disorder, cognitive disorder for diseases of cranial nerves
5.changes of another therapy for diabetes
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Hiyoshi |
Organization
Japan Red Cross Medical Center
Division name
Internal Medicine
Zip code
Address
4-1-22 Hiroo, Shibuya, Tokyo
TEL
03-3400-1311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Risa Eto |
Organization
Japan Red Cross Medical Center
Division name
Internal Medicine
Zip code
Address
4-1-22 Hiroo, Shibuy, Tokyo
TEL
03-3400-1311
Homepage URL
Sponsor or person
Institute
Japan Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Red Cross Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kitasato University, Graduate School of Medical Sciences, Department of Occupational Mental Health
Name of secondary funder(s)
Kitasato University, Graduate School of Medical Sciences, Department of Occupational Mental Health
IRB Contact (For public release)
Organization
Address
Tel
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
日本赤十字社医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 31 | Day |
Last modified on
| 2012 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008812
