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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027624
Receipt No. R000031650
Scientific Title New measurement method of glucagon in patients with heart disease
Date of disclosure of the study information 2017/06/06
Last modified on 2017/12/25

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Basic information
Public title New measurement method of glucagon in patients with heart disease
Acronym New glass study
Scientific Title New measurement method of glucagon in patients with heart disease
Scientific Title:Acronym New glass study
Region
Japan

Condition
Condition Patients with heart diseaes and non heart disease who had never diabetes
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the value of glucagon in patients with heart disease
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference value of AUC (area under the curve) glucagon in patient with or without heart disease(Sandwich ELISA).75gOGTT(oral glucose tolerance test) during 4h method.
Key secondary outcomes 1.Each 0 to 4h, difference value of glucagon (Sandwitc ELISA) in patients with or without heart disease.
2.Each 0 to 4h, difference value of glucagon (RIA) in patients with or without heart disease.
3.Difference value of AUC glucagon (RIA and Sandwich ELISA) in patients with heart disease.
4.Difference value of AUC glucagon (Sandwitc ELISA and RIA) in patients without heart disease.
5.Each 0 to 4h, difference value of glucagon (Sandwitc ELISA and RIA) in patients with heart disease.
6.Each 0 to 4h, difference value of glucagon (Sandwitc ELISA and RIA) in patients without heart disease.
7.Relation between each 0 to 4h and AUC value of glucagon (Sandwitc ELISA and RIA) in patients and cardiac functions(EF,E/A,E/E',rest and exercie heart rate, anaerobic threhsold, peak VO2, O2 pulse, PETCO2, minimum VE/VCO2, VE vs VCO2 slope)



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 with or without heart disease who had never diabetes
Key exclusion criteria 1.over HbA1c 8.0 percent
2.Uncontrol hemodynamics stage in heart disase
3.No informed consent
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Murata
Organization Gunma Prefectual Cardiovascular Center
Division name Deperatment of Cardiology
Zip code
Address 3-12,Kameizumi-Kou,Maebashi-city,Gunma-ken,Japan
TEL 027-269-7455
Email yarukimanmann2000@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Murata
Organization Gunma Prefectual Cardiovascular Center
Division name Deperatment of Cardiology
Zip code
Address 3-12,Kameizumi-Kou,Maebashi-city,Gunma-ken,Japan
TEL 027-269-7455
Homepage URL
Email yarukimanmann2000@yahoo.co.jp

Sponsor
Institute Gunma Prefectual Cardiovascular Center
Institute
Department

Funding Source
Organization Gunma Prefecture
Organization
Division
Category of Funding Organization Local Government
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
2017 Year 06 Month 06 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 Completed
Date of protocol fixation
2017 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 06 Day
Last follow-up date
2017 Year 09 Month 29 Day
Date of closure to data entry
2017 Year 09 Month 29 Day
Date trial data considered complete
2017 Year 10 Month 30 Day
Date analysis concluded
2017 Year 12 Month 25 Day

Other
Other related information We plan to claryfy the valuse of glucagon with RIA and Sandwich ELISA methods in patients with or without heart disease.
We perfome 4h oral glucose tolerance test each patents and sample of glucagon is investigated.

Management information
Registered date
2017 Year 06 Month 03 Day
Last modified on
2017 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031650

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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