UMIN-CTR Clinical Trial

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
Email	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
Email	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

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	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
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

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