UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020200 |
|---|---|
| Receipt number | R000023110 |
| Scientific Title | The efficacy of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors for pericardial fat in the type 2 diabetes patients |
| Date of disclosure of the study information | 2015/12/15 |
| Last modified on | 2015/12/22 09:36:13 |
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Basic information
Public title
The efficacy of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors for pericardial fat in the type 2 diabetes patients
Acronym
The efficacy of SGLT2 inhibitors for pericardial fat in the type 2 diabetes patients
Scientific Title
The efficacy of sodium-dependent glucose co-transporter 2(SGLT2) inhibitors for pericardial fat in the type 2 diabetes patients
Scientific Title:Acronym
The efficacy of SGLT2 inhibitors for pericardial fat in the type 2 diabetes patients
Region
| Japan |
Condition
Condition
Type 2 diabetes patients with pericardial fat is more than 125 ml
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with 125ml or more pericardial fat have been reported to have a high risk for ischemic heart disease. Sodium dependent glucose co-transporter 2(SGLT2) inhibitor Dapagliflozin has been reported as being approved in Europe and the United States and Japan, fewer side effects, weight loss, and abdominal visceral fat is reduced. This study is to investigate the efficacy of SGLT2 inhibitors for pericardial fat in the type 2 diabetes patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We administered the dapagliflozin to the patient, and observe the changes in the CT value of the amount and pericardial fat.
Key secondary outcomes
We will observe changes in the subjective symptoms, objective findings, and clinical examination (blood biochemistry, electrocardiogram, ABI). In addition, we will evaluate the safety of such adverse events.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who obtained the start or switching of consent the dapagliflozin of SGLT2 inhibitors.
2) Patients with pericardial fat is more than 125ml in coronary CT angiography.
3) Patient age of 20 years or older at the time of obtaining informed consent.
4) Patients who themselves can voluntarily provide consent to participate in this study, and can also follow the study protocol.
Key exclusion criteria
1)Patients with decreased renal function.
2)Patient corresponding to the contraindications and careful administration of SGLT2 inhibitors.
3)Patients research investigator has determined to be inappropriate as a patient.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehito Shizuka |
Organization
National Hospital Organization Takasaki General Medical Center
Division name
Division of Cardiology
Zip code
Address
36 Takamatsu-cho, Takasaki-city, Gunma
TEL
027-322-5901
tshizuka8@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehito Shizuka |
Organization
National Hospital Organization Takasaki General Medical Center
Division name
Division of Cardiology
Zip code
Address
36 Takamatsu-cho, Takasaki-city, Gunma
TEL
027-322-5901
Homepage URL
tshizuka8@gmail.com
Sponsor or person
Institute
National Hospital Organization Takasaki General Medical Center
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
| 2015 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:Prospective Cohort Study
Subject recruitment method:Patients were consistent with a visit to selection criteria to our facility in December 2015 to October 2016.
Management information
Registered date
| 2015 | Year | 12 | Month | 15 | Day |
Last modified on
| 2015 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023110
