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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025433
Receipt No. R000029264
Scientific Title A retrospective study to investigate the relationship between vascular endothelial function and glucose metabolism / lipid metabolism / blood pressure change.
Date of disclosure of the study information 2016/12/27
Last modified on 2016/12/27

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Basic information
Public title A retrospective study to investigate the relationship between vascular endothelial function and glucose metabolism / lipid metabolism / blood pressure change.
Acronym A retrospective study to investigate the relationship between vascular endothelial function and glucose metabolism / lipid metabolism / blood pressure change.
Scientific Title A retrospective study to investigate the relationship between vascular endothelial function and glucose metabolism / lipid metabolism / blood pressure change.
Scientific Title:Acronym A retrospective study to investigate the relationship between vascular endothelial function and glucose metabolism / lipid metabolism / blood pressure change.
Region
Japan

Condition
Condition Type 2 diabetes mellitus or Endocrine disorder
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the relationship between vascular endothelial function and glucose metabolism / lipid metabolism / blood pressure fluctuation evaluation item.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between vascular endothelial function and glucose metabolism / lipid metabolism / blood pressure fluctuation.
Key secondary outcomes

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

Not applicable
Gender Male and Female
Key inclusion criteria Those who received treatment for type 2 diabetes and endocrine disorders in our department.
Key exclusion criteria 1)Patients with severe renal dysfunction including dialysis patients
2)Diabetic ketoacidosis, diabetic coma
3)pregnancy or possible pregnancy
4)Patients judged unsuitable as other subjects judged by doctors
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Okada
Organization University of Occupational and
Environmental Health
Division name First Department of Internal Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushyu-shi, 807-8555, Japan
TEL 093-603-1611
Email y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiichi Torimoto
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushyu-shi, 807-8555, Japan
TEL 093-603-1611
Homepage URL
Email torimoto@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and
Environmental Health
Institute
Department

Funding Source
Organization University of Occupational and
Environmental Health
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
2016 Year 12 Month 27 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 Enrolling by invitation
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 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 Data of the subject cases are extracted from the medical record and compared retrospectively.

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029264

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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