UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019071 |
|---|---|
| Receipt number | R000022051 |
| Scientific Title | The effect of ipragliflozin on ectopic fat accumulation in non-obese type 2 diabetic patients with increased visceral fat |
| Date of disclosure of the study information | 2015/10/15 |
| Last modified on | 2017/02/04 12:37:06 |
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Basic information
Public title
The effect of ipragliflozin on ectopic fat accumulation in non-obese type 2 diabetic patients with increased visceral fat
Acronym
SGLT2 inhibitor and ectopic fat accumulation in diabetes
Scientific Title
The effect of ipragliflozin on ectopic fat accumulation in non-obese type 2 diabetic patients with increased visceral fat
Scientific Title:Acronym
SGLT2 inhibitor and ectopic fat accumulation in diabetes
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 whether ipragliflozin could reduce ectopic fat accumulation in non-obese type 2 diabetic patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of epicaridial fat volume from baseline at 12 weeks
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
Ipragliflozin 50 mg for 12 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes with BMI < 25.0 kg/m2 and HbA1c 6.5-9.0% and visceral fat area equal to or greater than 100 cm2
Key exclusion criteria
Patients who are taking SGLT2 inhibitors
Patients with insulin treatment
Patients with severe diabetic retinopathy
Patients who are hypersensitive to SGLT2 inhibitors
Patients with cogestive heart failure (NYHA classification class III or IV)
Patients with active infection, malignancy, severe liver or renal diseases
Patients who had recently received operation or had severe trauma
Patients who had experienced atherothrombotic events including myocardila infarction and/or stroke
Patients with severe ketosis or diabetic coma/pre-coma
Patients who are unable to figure out the consent due to dementia or impairment of consciousness
Pregnant women, lactating woman, women who are planning to get pregnant
Patients who were judged inadequate to enroll in the study by medical doctors
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-3813-6111
bouchi.mem@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryotaro Bouchi |
Organization
Tokyo Medical and Dental University
Division name
Department of Molecular Endocrinology and Metabolism, Graduate School of Medical and Dental Sciences
Zip code
Address
1-5-45 Yushima, Bunkyoku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
bouchi.mem@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 10 | Month | 15 | 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
| 2015 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 15 | 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
| 2015 | Year | 09 | Month | 19 | Day |
Last modified on
| 2017 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022051
