UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033541 |
|---|---|
| Receipt number | R000038245 |
| Scientific Title | The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy |
| Date of disclosure of the study information | 2018/07/28 |
| Last modified on | 2018/07/27 18:11:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
Acronym
The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
Scientific Title
The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
Scientific Title:Acronym
The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diabetic cardiac autonomic neuropathy (CAN) is difficult to benefit from cardiac rehabilitation in poorly controlled diabetic patients. We aim to reveal whether the addition of SGLT2 inhibitors improves diabetic CAN.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Heart rate recovery after exercise, heart rate variability parameters after three months of SGLT2 inhibitor treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Adiministration of SGLT2 inhibitors (empagliflozin 10mg/day or tofogliflozin 20mg/day) for three months of phase II cardiac rehabilitation
Interventions/Control_2
Adiministration of diabetic medication other than SGLT2 inhibitors for three months of phase II cardiac rehabilitation
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Diagnosed as type 2 diabetes mellitus with fasting blood glucose >=126mg/dL (or casual blood glucose >=200mg/dL) and HbA1c >=6.5%
(2) HbA1c >=7.0% at the beginning of cardiac rehabilitation
(3) Age >=20 years old and <90 years old
(4) Providing written informed consent on voluntary basis
Key exclusion criteria
(1) History of SGLT2 inhibitor treatment
(2) Associated with severe renal dysfunction
(3) Associated with respiratory disease
(4) History of cerebral infarction
(5) History of urinary / genital infection
(6) Women in pregnancy or at risk of becomming pregnant
(7) Breast-feeding woment
(8) Patients whom researchers rule out as prropriate subjects
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Miyu Tajima |
Organization
University of Tokyo Hospital
Division name
Cardiovascular department
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
mtajima-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miyu Tajima |
Organization
Sakakibara Heart Institute
Division name
Cardiovascular department
Zip code
Address
3-16-1, Asahi-cho, Fuchu-shi, Tokyo
TEL
042-314-3111
Homepage URL
mtajima-tky@umin.ac.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
Sakakibara Heart Institute
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
| 2018 | Year | 07 | Month | 28 | 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
| 2018 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | 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
| 2018 | Year | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038245
