UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025334 |
|---|---|
| Receipt number | R000029147 |
| Scientific Title | Effects of luseogliflozin on intravaginal bacteria and fungi in patients with type 2 diabetes |
| Date of disclosure of the study information | 2016/12/20 |
| Last modified on | 2016/12/20 15:16:34 |
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Basic information
Public title
Effects of luseogliflozin on intravaginal bacteria and fungi in patients with type 2 diabetes
Acronym
Effects of luseogliflozin on intravaginal bacteria and fungi
Scientific Title
Effects of luseogliflozin on intravaginal bacteria and fungi in patients with type 2 diabetes
Scientific Title:Acronym
Effects of luseogliflozin on intravaginal bacteria and fungi
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate of effects of luseogliflozin on intravaginal bacteria and fungi
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intravaginal fungi and Gram-positive and -negative bacilli
Key secondary outcomes
Body mass index, HbA1c, and serum triglyceride and total, HDL, and LDL cholesterol levels
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
| 25 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
Type 2 diabetes patients.
Obtained written informed consent from the patients before participation.
Key exclusion criteria
Having severe nephropathy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Kusunoki |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
052-789-3946
info@tonyo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masataka Kusunoki |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
052-789-3946
Homepage URL
info@tonyo.jp
Sponsor or person
Institute
Research Center of Health, Physical Fitness and Sports, Nagoya University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2016 | Year | 12 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 20 | Day |
Other
Other related information
Female patients with type 2 diabetes are divided into two group: premenopausal and postmenopausal groups. Each patient are administered SGLT2 inhibitor luseogliflozin once daily at a dose level 2.5 mg for 6 months. Immediately before and after 6 months of luseogliflozin treatment, vaginal secretions are collected, and the secretions collected are incubated in media for identification and quantification of the bacteria. Body weight is measured immediately before and at the end of 6 months of luseogliflozin treatment. Blood samples are obtained before and after the treatment to measure HbA1c and serum triglyceride and HDL and LDL cholesterol levels.
Management information
Registered date
| 2016 | Year | 12 | Month | 20 | Day |
Last modified on
| 2016 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029147
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
