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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017770 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Type 2 diabetes | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | Type 1 DM
history of arrythmia Severe diabetic neuropathy history of pancreatitis Pregnancy |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Dokkyomedical university nikko medical center |
Institute | |
Department |
Funding Source | |
Organization | Dokkyomedical university nikko medical center |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020584 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |