UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000019899
Receipt No. 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 (Ver. 7)

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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
Email 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
Email kgmgt942@ybb.ne.jp

Sponsor
Institute Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022659