UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019899 |
|---|---|
| Receipt number | R000022659 |
| Scientific Title | Clinical study of the changes in platelet function and coagulation in insulin tolerance test |
| Date of disclosure of the study information | 2015/11/23 |
| Last modified on | 2019/11/26 09:19:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical study of the changes in platelet function and coagulation in insulin tolerance test
Acronym
Clinical study of the changes in platelet function and coagulation in insulin
tolerance test
Scientific Title
Clinical study of the changes in platelet function and coagulation in insulin tolerance test
Scientific Title:Acronym
Clinical study of the changes in platelet function and coagulation in insulin
tolerance test
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of hypoglycemia on platelet function and coagulation
Basic objectives2
Others
Basic objectives -Others
It is evaluated by using the T-TAS(Total Thrombus-formation Analysis System)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC10, area under curve until 10 min for PL chip on T-TAS(Total Thrombus-formation Analysis System) and plasma
catecholamines at 0min,15min,30min,60min, 90min, 120min before and after insulin load
Key secondary outcomes
1)plasma PAI-1(plasminogen activator inhibitor-1)
2) P-selectin and PAC-1 by flowcytometry
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
| Not applicable |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who insulin tolerance test is determined to be necessary for pituitary function assessment
Key exclusion criteria
65 years of age or older patients,
Patients with a history of ischemic heart disease and seizures
Patients who has oral anti-platelet drug or anticoagulant drug
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Nishio |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Diabetes and Endocrinology
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-6478
info@kadai-tounai.com
Public contact
Name of contact person
| 1st name | Kiyoaki |
| Middle name | |
| Last name | Yamamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Diabetes and Endocrinology
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-6478
Homepage URL
kgmgt942@ybb.ne.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kagoshima University Graduate School of Medicine and Dentistry
Address
8-35-1, Sakuragaoka, Kagoshima 890-8544, Japan
Tel
099-275-5318
kufsyomu@kuas.kagoshima-u.ac.jp
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
| 2015 | Year | 11 | Month | 23 | 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
Ten subjects were included. Along with the hypoglycemia, epinephrine were significantly changed. There was a correlation between the decrease in plasma glucose and the change of epinephrine Further,the change of epinephrine was correlated with change of T10 and OT.
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 | 07 | Month | 18 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Subjects:all patients who are admitted to Kagoshima University Hospital from September 30, 2014 until July 31, 2016 and meets the selection criteria
Outcomes(at0min,15min,30min,60min,90min,120min after insulin load)
1)T-TAS:
a.T10(Time pressure in the chip reaches to 10kPa from test start)
b.T10-80(Time until the pressure in the chip rises from 10kPa to 80kPa)
c.OT occlusion time(Time from the test start to 80kPa)
2)plasma PAI-1
3)P-selectin and PAC-1 by flowcytometry
Management information
Registered date
| 2015 | Year | 11 | Month | 23 | Day |
Last modified on
| 2019 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022659
