UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022561 |
|---|---|
| Receipt number | R000025981 |
| Scientific Title | Investigation of the visceral fat and adipocytokine by SGLT2 inhibitors in type 2 diabetes millitus |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2018/03/12 08:52:31 |
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Basic information
Public title
Investigation of the visceral fat and adipocytokine by SGLT2 inhibitors in type 2 diabetes millitus
Acronym
Impact on the visceral fat and adipocytokine by SGLT2 inhibitors
Scientific Title
Investigation of the visceral fat and adipocytokine by SGLT2 inhibitors in type 2 diabetes millitus
Scientific Title:Acronym
Impact on the visceral fat and adipocytokine by SGLT2 inhibitors
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect on visceral fat and adipocytokine by SGLT2 inhibitors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat
Body composition
Body weight
Lipid
Adipocytokine
Key secondary outcomes
HbA1c
Fasting plasma glucose
Serum Insulin
Glycogen
Serum ketone body
Urinary glucose excretion
Urinary albumin
Blood pressure
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Divide in the preceding administration group and the trailing administered group.
Preceding administration group to medication the SGLT2 inhibitor for about 12 weeks. After that, this group to abort the SGLT2 inhibitor and observe for about 12 weeks.
We prescribe only Dapagliflozin 5mg in this study.
Interventions/Control_2
Trailing administration group to observe for about 12 weeks in reverse order.
We prescribe only Dapagliflozin 5mg in this study.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women who were diagnosed with type 2 diabetes.
Patients who are considered treatment with SGLT2 inhibitors is suitable.
Patients who are obtained informed consent.
Key exclusion criteria
1.Type 1 diabetes, secondary diabetes
2.Severe ketosis, diabetic coma, or before coma
3.Severe infection, before and not long after surgery, or patients with severe trauma
4.Severe cerebrovascular dysfunction, heart disorder, renal dysfunction and liver dysfunction
5.Heart failure(NYHA classification 3-4), patients treated by diuretic
6.Patients who have repeated urinary tract infections
7.Alchole intake excessive
8.Women suspected of pregnancy or pregnant
9.Patients with a history of use SGLT2 inhibitors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Aso |
Organization
Dokkyo medical university
Division name
Endocrinology and Metabolism
Zip code
Address
880 Kitakobashi, Mibu, Shimotsuga-gun,Tochigi,JAPAN
TEL
0282-86-1111
yaso@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Sagara |
Organization
Dokkyo medical university
Division name
Endocrinology and Metabolism
Zip code
Address
880 Kitakobashi, Mibu, Shimotsuga-gun,Tochigi,JAPAN
TEL
0282-86-1111
Homepage URL
sgrmsak@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo medical university, Endocrinology and Metabolism
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 | 06 | Month | 10 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | 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
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025981
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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