UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038489 |
|---|---|
| Receipt number | R000043861 |
| Scientific Title | Changes in continuous glucose monitoring during sleep in OSA patients without diabetes before and after CPAP treatment |
| Date of disclosure of the study information | 2020/12/29 |
| Last modified on | 2022/01/23 11:57:10 |
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Basic information
Public title
Changes in continuous glucose monitoring during sleep in OSA patients without diabetes before and after CPAP treatment
Acronym
SAS and continuous glucose monitoring
Scientific Title
Changes in continuous glucose monitoring during sleep in OSA patients without diabetes before and after CPAP treatment
Scientific Title:Acronym
SAS and continuous glucose monitoring
Region
| Japan |
Condition
Condition
sleep apnea syndrome
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between sleep apnea syndrome(SAS)and continuous glucose monitoring(CGM)and the effect of Positive Airway Pressure treatment(CPAP) on CGM.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of CPAP treatment on continuous glucose monitoring 1 week before and after the start of treatment.
Key secondary outcomes
The relationship between sleep apnea syndrome and continuous glucose monitoring.
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 |
Interventions/Control_1
1 week of CPAP treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)SAS patients with AHI 15 or greater.
2)patients with informed concent.
Key exclusion criteria
1) Patients with a history of diabetes treatment.
2) CPAP usage time less than 4 hours
3) Patients whose measured blood glucose level and CGM difference is 20mg / dl or more
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | KIMIMASA |
| Middle name | |
| Last name | SAITO |
Organization
Medical corporation MSC
Division name
Mie Sleep Clinic
Zip code
5190502
Address
446 sogo obata Ise,MIe
TEL
+81-596-29-1159
k1saito@carrot.ocn.ne.jp
Public contact
Name of contact person
| 1st name | KIMIMASA |
| Middle name | |
| Last name | SAITO |
Organization
Medical corporation MSC
Division name
Mie Sleep Clinic
Zip code
5190502
Address
446 sogo obata Ise,MIe
TEL
+81-596-29-1159
Homepage URL
k1saito@carrot.ocn.ne.jp
Sponsor or person
Institute
Medical corporation MSC
Mie Sleep Clinic
Institute
Department
Personal name
Funding Source
Organization
Medical corporation MSC
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
Medical corporation MSC
Address
446 sogo obata Ise,MIe
Tel
+81-596-29-1159
k1saito@carrot.ocn.ne.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
医療法人MSC 三重スリープクリニック（三重県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs11325-021-02442-9
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs11325-021-02442-9
Number of participants that the trial has enrolled
42
Results
SD of GV during sleep correlated significantly with sleep time spent with oxygen saturation <90%. HBGI during sleep correlated significantly with stage N1% and negatively with stage N2%. HIBI correlated significantly with sleep time spent with oxygen saturation <90% (r=0.640,p=0.003). REMrelated OSA group had a higher incidence of hypoglycemia. One week CPAP treatment significantly improved GV during sleep,and high blood glucose index.
Results date posted
| 2022 | Year | 01 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A prospective intervention study of 42 patients with normal glucose tolerance OSA and 13 healthy subjects
Participant flow
The present prospective observational study included patients who visited Mie Sleep Clinic, Mie, Japan, between 1 December 2018 and 31 May 2020. Patients who have been admitted to overnight PSG and have not received diabetes treatment. All patients provided written informed consent after information regarding the study procedure and content had been provided. This study was approved by the Institutional Review Board (IRB) of Medical corporation MSC (reference number: 17001, UMIN 000038489), and University of Occupational and Environmental Health School of Medicine (Trial registration: H27-186, Registered 25 Dec 2015, UMIN 000025433) and was carried out in accordance with the Declaration of Helsinki.
Adverse events
None
Outcome measures
The primary endpoints were the comparison of blood glucose variability during sleep between the OSA group and the healthy group, the association with various sleep-disordered breathing indices, and the change in blood glucose variability during sleep after CPAP treatment. Secondary endpoints were the characteristics of blood glucose variability by OSA subtype.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 04 | Day |
Last modified on
| 2022 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043861
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