UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019292 |
|---|---|
| Receipt number | R000022288 |
| Scientific Title | The clinical research of the relationship between glycemic control evaluation and oxidative stress and vascular endothelial dysfunction in the diabetes patient, with Evaluation of a new measure of blood glucose variability ,"ADRR" |
| Date of disclosure of the study information | 2015/10/09 |
| Last modified on | 2021/03/09 10:07:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The clinical research of the relationship between glycemic control evaluation and oxidative stress and vascular endothelial dysfunction in the diabetes patient, with Evaluation of a new measure of blood glucose variability ,"ADRR"
Acronym
ADRR (Average daily risk range) and oxidative stress/vascular endothelial dysfunction
Scientific Title
The clinical research of the relationship between glycemic control evaluation and oxidative stress and vascular endothelial dysfunction in the diabetes patient, with Evaluation of a new measure of blood glucose variability ,"ADRR"
Scientific Title:Acronym
ADRR (Average daily risk range) and oxidative stress/vascular endothelial dysfunction
Region
| Japan |
Condition
Condition
Patients on insulin therapy
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify and blood sugar fluctuations evaluation using ADRR in diabetic patients on insulin therapy, oxidative stress is an important factor in cardiovascular disease onset, the relevance of the vascular endothelial dysfunction and atherosclerosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADRR(Average daily risk range)
Oxidative stress marker (serum 3-nitro-tyrosine, urinary 8-OHdG / Cr, urinary 8-iso-PGF2 alpha / Cr)
(After 4 months of start of the study)
Key secondary outcomes
Blood sugar-related inspection: HbA1c, glycated albumin, blood glucose level, 1.5-AG
FMD:Flow Mediated Dilation
High sensitivity CRP
Urinary albumin / creatinine ratio
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Johnson & Johnson
Blood glucose meter
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Patient who is doing a self monitoring of blood glucose and a self-insulin injection.
(2) Patient who is doing the insulin injection from before more than 6 months at the registration.
(3)Individual who has the ability of consent and can sign a written informed consent
Key exclusion criteria
(1)Individual who has a smoking habit.
(2)Patient with depression, alcohol-dependent patient.
(3)Cancer patient
(4)Patient who has taken a medication which affects to blood glucose levels, such as steroid, anti-cancer agent and interferon.
(5)Woman who is pregnant, or possibility of pregnant, or wishes to pregnant, or lactating
(6)Individual who is considered unsuitable for inclusion by the attending physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Koya |
Organization
Kanazawa Medical University
Division name
Daibetology & Endocrinology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa, 920-0293
TEL
076-286-2211
koya0516@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Kuroshima |
Organization
Kanazawa Medical University
Division name
Daibetology & Endocrinology
Zip code
920-0293
Address
1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa, 920-0293
TEL
076-286-2211
Homepage URL
naipicrc@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Kanazawa Medical University Hospital Clinical trials study center
Address
1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa
Tel
076-286-3511
tiken@kanazawa-med.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
金沢医科大学病院/Kanazawa Medical University Hospital.
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 09 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022288
