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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033541
Receipt No. 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

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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
Email 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
Email mtajima-tky@umin.ac.jp

Sponsor
Institute Sakakibara Heart Institute
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038245

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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