UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007777 |
|---|---|
| Receipt number | R000009107 |
| Scientific Title | Relationships between blood glucose level, cardiac autonomic function and occurrence of arrhythmia in using oral hypoglycemic or antiarrhythmic drugs. |
| Date of disclosure of the study information | 2012/04/17 |
| Last modified on | 2012/04/17 11:19:27 |
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Basic information
Public title
Relationships between blood glucose level, cardiac autonomic function and occurrence of arrhythmia in using oral hypoglycemic or antiarrhythmic drugs.
Acronym
GLAFITE study
Scientific Title
Relationships between blood glucose level, cardiac autonomic function and occurrence of arrhythmia in using oral hypoglycemic or antiarrhythmic drugs.
Scientific Title:Acronym
GLAFITE study
Region
| Japan |
Condition
Condition
Type1 and type2 diabetes mellitus, tachyarrhythmia
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
...
Basic objectives2
Others
Basic objectives -Others
...
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
...
Key secondary outcomes
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
Patients who meet both criterias shown below sholud be included.
1)Those who is under drug treatment with diagnosis of diabetes mellitus.
2)Adults.
Key exclusion criteria
Patients who meet any criterias shown below sholud be excluded.
1)Those who can not write consent.
2)Patients who are considered inappropriate to mount continuous monitoring device.
3)Anyone whom our person in charge regaerd unsuitable for the present study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine and Science
Zip code
Address
1-8-1 Inohana Chuoku Chiba sity Chiba pref.
TEL
043-222-7171
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine and Science
Zip code
Address
TEL
043-222-7171
Homepage URL
Sponsor or person
Institute
Chiba University Graduate School of Medicine, Department of Cardiovascular Medicine and Science
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 04 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
Under collecting patients profiles.
Management information
Registered date
| 2012 | Year | 04 | Month | 17 | Day |
Last modified on
| 2012 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009107
