UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017770 |
|---|---|
| Receipt number | R000020584 |
| Scientific Title | The influence of GLP-1 receptor agonist on the heart rate using holter electrocardiography and power spectrum analysis on heart rate variability |
| Date of disclosure of the study information | 2015/06/02 |
| Last modified on | 2015/06/02 15:41:55 |
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Basic information
Public title
The influence of GLP-1 receptor agonist on the heart rate using holter electrocardiography and power spectrum analysis on heart rate variability
Acronym
The influence of GLP-1 receptor agonist on the heart rate
Scientific Title
The influence of GLP-1 receptor agonist on the heart rate using holter electrocardiography and power spectrum analysis on heart rate variability
Scientific Title:Acronym
The influence of GLP-1 receptor agonist on the heart rate
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Several studies have reported that GLP-1 receptor agonists (GLP-1RA) increase the heart rate, but no study on the difference between long- and short-acting GLP-1RA has been reported. We performed Holter electrocardiography and power spectrum analysis of heart rate variability before and after the administration of a long-acting GLP-1RA, Liraglutide, and a short-acting GLP-1RA, Lixisenatide, and compared the influences on the heart rate and autonomic nervous system between the 2 drugs.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24h-heart rate
Holter electrocardiograph
Power spectrum analysis
before or after 2h meal and night time glucose
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Liraglutide group
Interventions/Control_2
Lixisenatide group
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient with type 2 DM doing a hospitalizing for diabetes
Patients with no history of treatment to GLP-1 or DDP-4 inhibitor
Key exclusion criteria
Type 1 DM
history of arrythmia
Severe diabetic neuropathy
history of pancreatitis
Pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakatai Yuki |
Organization
Dokkyomedical university nikko medical center
Division name
Diabates and endcrinology
Zip code
Address
632 takatoku,nikkoshi,tochigi
TEL
0288-76-1515
yu-naka@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nakatani Yuki |
Organization
Dokkyomedical university nikko medical center
Division name
Diabates and endcrinology
Zip code
Address
632 takatoku,nikkoshi,tochigi
TEL
0288-76-1515
Homepage URL
yu-naka@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyomedical university nikko medical center
Institute
Department
Personal name
Funding Source
Organization
Dokkyomedical university nikko medical center
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
獨協医科大学日光医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 02 | Day |
Last modified on
| 2015 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020584
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
