Unique ID issued by UMIN | UMIN000033541 |
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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 |
The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
Japan |
diabetes mellitus
Cardiology | Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Heart rate recovery after exercise, heart rate variability parameters after three months of SGLT2 inhibitor treatment
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Adiministration of SGLT2 inhibitors (empagliflozin 10mg/day or tofogliflozin 20mg/day) for three months of phase II cardiac rehabilitation
Adiministration of diabetic medication other than SGLT2 inhibitors for three months of phase II cardiac rehabilitation
20 | years-old | <= |
90 | years-old | > |
Male and Female
(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
(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
200
1st name | |
Middle name | |
Last name | Miyu Tajima |
University of Tokyo Hospital
Cardiovascular department
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
mtajima-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Miyu Tajima |
Sakakibara Heart Institute
Cardiovascular department
3-16-1, Asahi-cho, Fuchu-shi, Tokyo
042-314-3111
mtajima-tky@umin.ac.jp
Sakakibara Heart Institute
Sakakibara Heart Institute
Self funding
NO
2018 | Year | 07 | Month | 28 | Day |
Unpublished
Preinitiation
2018 | Year | 07 | Month | 28 | Day |
2018 | Year | 10 | Month | 01 | Day |
2018 | Year | 07 | Month | 27 | Day |
2018 | Year | 07 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038245
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