UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027624 |
|---|---|
| Receipt number | 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 22:39:53 |
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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
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
yarukimanmann2000@yahoo.co.jp
Sponsor or person
Institute
Gunma Prefectual Cardiovascular Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031650
