UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031793 |
|---|---|
| Receipt number | R000036145 |
| Scientific Title | An exploratory clinical study on the effects of SGLT2 inhibitors for type 2 diabetes (T2DM) patients with sleep apnea (SA) |
| Date of disclosure of the study information | 2018/03/19 |
| Last modified on | 2024/12/04 14:36:49 |
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Basic information
Public title
An exploratory clinical study on the effects of SGLT2 inhibitors for type 2 diabetes (T2DM) patients with sleep apnea (SA)
Acronym
An exploratory clinical study on the effects of SGLT2 inhibitors for type 2 diabetes (T2DM) patients with sleep apnea (SA)
Scientific Title
An exploratory clinical study on the effects of SGLT2 inhibitors for type 2 diabetes (T2DM) patients with sleep apnea (SA)
Scientific Title:Acronym
An exploratory clinical study on the effects of SGLT2 inhibitors for type 2 diabetes (T2DM) patients with sleep apnea (SA)
Region
| Japan |
Condition
Condition
sleep apnea
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to determine whether SGLT2 inhibitors reduce the severity of SA through the weight reduction in patients with T2DM.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in apnea-hypopnea index (AHI), body weight, body composition, and HbA1c, as well as the levels of microalbuminuria and urine L-FABP
Key secondary outcomes
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
| Medicine |
Interventions/Control_1
Sodium glucose cotransporter 2inhibitor
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
Apnea Hypopnea Index over 15 patients with type 2 DM
Key exclusion criteria
Patients with moderate renal disease (eGFR<30 ml/min)
patients with ketosis and diabetic coma
patients with severe infection, perioperative period and severe trauma
patients with poor control DM
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine, Cardiovascular Respiratory Sleep Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
03-3813-3111
tkasai@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kasai |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine, Cardiovascular Respiratory Sleep Medicine
Zip code
113-8431
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan.
TEL
03-3813-3111
Homepage URL
tkasai@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
we have no funding source
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
Juntendo University Medical Research Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, Japan.
Tel
03-3814-5672
jcrtc_operation@juntendo.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
| 2018 | Year | 03 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 13 | 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
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036145
