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

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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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022659


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name