UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025433 |
|---|---|
| Receipt number | 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 15:28:49 |
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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
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
torimoto@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and
Environmental Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029264
