UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045226 |
|---|---|
| Receipt number | R000050705 |
| Scientific Title | Effects of treatment with SGLT2 inhibitor on the initiation of continuous positive airway pressure therapy in type 2 diabetic patients with obstructive sleep apnea syndrome |
| Date of disclosure of the study information | 2021/08/23 |
| Last modified on | 2021/08/23 13:02:06 |
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Basic information
Public title
Effects of treatment with SGLT2 inhibitor on the initiation of continuous positive airway pressure therapy in type 2 diabetic patients with obstructive sleep apnea syndrome
Acronym
Effects of treatment with SGLT2 inhibitor on the initiation of C-PAP therapy in type 2 diabetic patients with obstructive sleep apnea syndrome
Scientific Title
Effects of treatment with SGLT2 inhibitor on the initiation of continuous positive airway pressure therapy in type 2 diabetic patients with obstructive sleep apnea syndrome
Scientific Title:Acronym
Effects of treatment with SGLT2 inhibitor on the initiation of C-PAP therapy in type 2 diabetic patients with OSAS
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To follow the effects of SGLT2 inhibitor in type 2 diabetic patients having obstructive sleep apnea syndrome at initiation of C-PAP therapy for 3 months.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c, BMI, and apnea-hypopnea index
Key secondary outcomes
Serum lipid profile, serum parameters of hepatic function, and serum uric acid level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The type 2 diabetic patients having obstructive sleep apnea syndrome are treated with 2.5 mg/day luseogliflozin, 5 mg/day dapagliflozin, or 10 mg/day empagliflozin for more than 6 months. And then the glycemic control of the patients is followed for 3 months without C-PAP therapy.
Interventions/Control_2
The type 2 diabetic patients having obstructive sleep apnea syndrome are treated with 2.5 mg/day luseogliflozin, 5 mg/day dapagliflozin, or 10 mg/day empagliflozin for more than 6 months, and then are initiated on C-PAP therapy. The glycemic control of the patients is followed for 3 months.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hemoglobin A1c level: 6.5-9.5%
Key exclusion criteria
eGFR<45 mL/min/1.73 m2
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Kusunoki |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
052-789-3946
kusunoki@tonyo.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Kusunoki |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
052-789-3946
Homepage URL
kusunoki@tonyo.jp
Sponsor or person
Institute
Akishima Clinic
Institute
Department
Personal name
Funding Source
Organization
Akishima Clinic
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
Akishima Clinic
Address
4-2-29 Sakae, Naka-ku, Nagoya
Tel
052-243-1024
info@tonyo.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
医療法人社団織田会あきしまクリニック（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 23 | 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
16
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 23 | Day |
Last modified on
| 2021 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050705
