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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034670
Receipt No. R000039525
Official scientific title of the study 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

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Basic information
Official scientific title of the study RH-PAT in the patients with type two diabetes (a retrospective study)
Title of the study (Brief title) 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 Rikako Ukichi
Organization Jikei University School of Medicine
Division name Diabetes, metabolism and endocrinology
Address Nishishimbashi, 3-25-8, Minato-ku, Tokyo
TEL 0334331111
Email risuzuki@jikei.ac.jp

Public contact
Name of contact person Rikako Ukichi
Organization Jikei University School of Medicine
Division name Diabetes, metabolism and endocrinology
Address Nishishimbashi, 3-25-8, Minato-ku, Tokyo
TEL 0334331111
Homepage URL
Email risuzuki@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.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


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