UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034670
Receipt number R000039525
Scientific Title RH-PAT in the patients with type two diabetes (a retrospective study)
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/27 23:11:05

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Basic information

Public title

RH-PAT in the patients with type two diabetes (a retrospective study)

Acronym

RH-PAT in the patients with type two diabetes

Scientific Title

RH-PAT in the patients with type two diabetes (a retrospective study)

Scientific Title:Acronym

RH-PAT in the patients with type two diabetes

Region

Japan


Condition

Condition

type two diabetes mellitus

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We performe RH-PAT to the patients who are admitted to our hospital for blood glucose control. We aim to see the association between the RHI and the clinical conditions.

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

RHI to see the function of vascular endothelium during the hospitalization for the control of blood glucose.

Key secondary outcomes

none


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

type two diabetes patients who are admitted to our hospital for the control of the blood glucose control

Key exclusion criteria

patiens with infectious disease, diabetic ketoacidosis, myocardial infarction

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Rikako Ukichi

Organization

Jikei University School of Medicine

Division name

Diabetes, metabolism and endocrinology

Zip code


Address

Nishishimbashi, 3-25-8, Minato-ku, Tokyo

TEL

0334331111

Email

risuzuki@jikei.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Rikako Ukichi

Organization

Jikei University School of Medicine

Division name

Diabetes, metabolism and endocrinology

Zip code


Address

Nishishimbashi, 3-25-8, Minato-ku, Tokyo

TEL

0334331111

Homepage URL


Email

risuzuki@jikei.ac.jp


Sponsor or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Jikei University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

2018 Year 11 Month 01 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

2016 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We aime to see the association between the microvascular damage, coexisting diseases of the type two diabetes and endovascular damage.


Management information

Registered date

2018 Year 10 Month 27 Day

Last modified on

2018 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039525


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name