UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054555 |
|---|---|
| Receipt number | R000062337 |
| Scientific Title | Evaluation of effectiveness of SGLT2 inhibitor on the sleep quality |
| Date of disclosure of the study information | 2024/06/03 |
| Last modified on | 2024/06/03 18:56:23 |
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Basic information
Public title
Evaluation of effectiveness of SGLT2 inhibitor on the sleep quality
Acronym
Evaluation of effectiveness of SGLT2 inhibitor on the sleep quality
Scientific Title
Evaluation of effectiveness of SGLT2 inhibitor on the sleep quality
Scientific Title:Acronym
Evaluation of effectiveness of SGLT2 inhibitor on the sleep quality
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of SGLT2 inhibitors on sleep quality in patients with type 2 diabetes remain unknown. We will investigate the effects of SGLT2 inhibitors on sleep quality in patients with type 2 diabetes mellitus and explore the factors that influence sleep quality.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of change of sleep quality between the patients with type 2 diabetes mellitus with/without SGLT2 inhibitor add-on treatment
Key secondary outcomes
The factors that associate with changes in sleep quality with the use of add-on SGLT2 inhibitors
Influence of SGLT2 inhibitor and other antidiabetic drugs on the nocturia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes mellitus
Key exclusion criteria
Patients who are taking diuretics
Patients with dementia or requiring long-term care, who cannot answer the questionnaire survey by themselves
Patients who have added or changed their antidiabetic drugs or insulin injection within the past three months
Patients who have had SGLT2 inhibitor within the past six months
Target sample size
82
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Inoguchi |
Organization
Department of Internal Medicine, Kurume University School of Medicine
Division name
Division of Endocrinology and Metabolism
Zip code
830-0011
Address
67 Asahi-Machi, Kurume, Fukuoka, Japan
TEL
0942-31-7563
inoguchi_yukihiro@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Inoguchi |
Organization
Department of Internal Medicine, Kurume University School of Medicine
Division name
Division of Endocrinology and Metabolism
Zip code
830-0011
Address
67 Asahi-Machi, Kurume, Fukuoka, Japan
TEL
0942-31-7563
Homepage URL
inoguchi_yukihiro@kurume-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Kurume University School of Medicine
Address
67 Asahi-Machi, Kurume, Fukuoka, Japan
Tel
0942-31-7563
i_rinri@kurume-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
| 2024 | Year | 06 | Month | 03 | 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
| 2024 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Patients with type 2 diabetes under treatment at Division of Endocrinology and Metabolism, Department of Internal Medicine, Kurume University Hospital who fulfilled the inclusion/ exclusion criteria.
Recruitment period : from June 5,2024 to March 31,2025
Evaluate the difference of change of sleep quality between the patients with type 2 diabetes mellitus with/without SGLT2 inhibitor add-on treatment
Management information
Registered date
| 2024 | Year | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062337
