UMIN-CTR Clinical Trial

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
Email	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
Email	naipicrc@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022288