UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045728 |
|---|---|
| Receipt number | R000051193 |
| Scientific Title | The impact of the improvement of glycometabolism in patients with type 2 diabetes on sleep disturbance including sleep disordered breathing following an admission to control their glucose metabolism. |
| Date of disclosure of the study information | 2021/10/18 |
| Last modified on | 2023/07/11 10:06:59 |
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Basic information
Public title
The impact of the improvement of glycometabolism in patients with type 2 diabetes on sleep disturbance including sleep disordered breathing following an admission to control their glucose metabolism.
Acronym
The impact of the improvement of glycometabolism on sleep disturbance including sleep apnea.
Scientific Title
The impact of the improvement of glycometabolism in patients with type 2 diabetes on sleep disturbance including sleep disordered breathing following an admission to control their glucose metabolism.
Scientific Title:Acronym
The impact of the improvement of glycometabolism on sleep disturbance including sleep apnea.
Region
| Japan |
Condition
Condition
type 2 diabetes with sleep disturbance including sleep disordered breathing
Classification by specialty
| Pneumology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although it is said that there is a significant relationship between sleep disturbance including sleep disordered breathing (SDB) and glycometabolism, there is little evidence whether the improvement of glucose metabolism has a significant effect on sleep disturbance. A hospitalization to control glucose metabolism may have several effects on patients with type 2 diabetes such as body weight change, insulin resistance and etc, which would have an impact on sleep disturbance. Therefore, to explore the bidirectional relationship between sleep disturbance and glucose metabolism, we investigate sleep disturbance in patients with type 2 diabetes following the hospitalization.
Basic objectives2
Others
Basic objectives -Others
To explore the causal relationship between sleep disturbance including sleep disordered breathing and glucose metabolism (blood sugar levels, insulin resistance,body weight,dietary habits).
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in the severity of sleep disturbance such as respiratory event index, objective sleep duration, the severity of sleep disruption, and sleep latency)
Key secondary outcomes
Blood sugar level
HOMA-IR
HOMA-beta
BMI
Lipid metabolism
ABI(Ankle - Brachial Index)
PWV(PulseWave Velocity)
Intima Media Thickness
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Acti Watch
The actiwatch is a wrist watch that records physical movement and light constantly and provides us information about a patient's sleep, wake pattern, and sleep duration.
Duration: From 2 to 7 days before, during hospitalization, and following 3 months of admission.
Frequency:24 hours/day during each intervention.
FreeStyle Libre Pro
FreeStyle Libre Pro is a device that records glucose level up to 14 days by glucose concentration in interstitial fluid.
Duration:During the admission
Frequency:24hours/day during the admission.
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
Patients with type 2 diabetes who are admitted to control their glucose metabolism
Key exclusion criteria
1.Patients who were already diagnosed as sleep apnea syndrome and treated.
2.Patients with diabetes who were diagnosed as not tyoe 2 but the others.
3.Patients with diabetic ketosis or ketoacidosis
4.Patients with cancer
5.Patients taking corticosteroids.
6.Patients on oxygen therapy
7.Patients with hemodialysis
8.Patients with a cardiac pacemaker
9.Premenoposal female
10. Patients with physical activity restrictions due to disability
11.Patients who refuse to participate in this trial.
12. Patients who are judged to be inappropriate as a candidate by the doctor.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Chin |
Organization
Nihon University of Medicine
Division name
Department of Sleep Medicine and Respiratory Care Division of Sleep Medicine Department of Internal Medicine
Zip code
173-8610
Address
30-1, Oyaguchi kami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
chin.kazuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Mamiko |
| Middle name | |
| Last name | Hoshi |
Organization
Graduate school of medicine, Nihon university
Division name
Respitory medicine
Zip code
173-8610
Address
30-1, Oyaguchi kami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
mema21005@g.nihon-u.ac.jp
Sponsor or person
Institute
Nihon University of Medicine
Institute
Department
Personal name
Funding Source
Organization
1.Japan Agency for Medical Research and Development
2.Grants-in-aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University of Medicine
Address
30-1, Oyaguchi kami-cho, Itabashi-ku, Tokyo
Tel
03-3972-8111
med.itabashi.chiken@nihon-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
| 2021 | Year | 10 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051193
