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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013403
Receipt No. R000015317
Scientific Title Relationship between 1,5-anhydro-D-glucitol and vascular endothelial function in type 2 diabetes
Date of disclosure of the study information 2014/03/12
Last modified on 2014/11/15

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Basic information
Public title Relationship between 1,5-anhydro-D-glucitol and vascular endothelial function in type 2 diabetes
Acronym Relationship between 1,5-AG and endothelial function
Scientific Title Relationship between 1,5-anhydro-D-glucitol and vascular endothelial function in type 2 diabetes
Scientific Title:Acronym Relationship between 1,5-AG and endothelial function
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we investigate the relationship between vascular endothelial dysfunction and 1,5-anhydro-D-glucitol, a marker that reflects both postprandial hyperglycemia and fluctuations in blood glucose.
Basic objectives2 Others
Basic objectives -Others The cross-sectional study investigate relationship between 1,5-anhydro-D-glucitol and vascular endothelial function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The reactive hyperaemia index values obtained are examined for any relationship with 1,5-anhydro-D-glucitol, glucose or lipid metabolism markers, and blood pressure.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) age 20 and above; (2) HbA1c < 8.0%; (3) Cre < 2.0 mg/dl; and (4) the absence of arrhythmias.
Key exclusion criteria Patients with diabetic ketoacidosis, nonketotic hyperosmolar coma, infection, or acute coronary syndrome are excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Okada
Organization School of Medicine, 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 School of Medicine, 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 090-603-1611
Homepage URL
Email torimoto@med.uoeh-u.ac.jp

Sponsor
Institute First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
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
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
2014 Year 03 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 10 Day
Last follow-up date
2014 Year 01 Month 01 Day
Date of closure to data entry
2014 Year 01 Month 01 Day
Date trial data considered complete
2014 Year 01 Month 01 Day
Date analysis concluded
2014 Year 01 Month 01 Day

Other
Other related information This is a cross-sectional study.
On the second or third hospital day, patients undergo fasted blood testing to measure HbA1c, 1,5-anhydro-D-glucitol (1,5-AG), fasting plasma glucose, immunoreactive insulin (IRI), low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglyceride, as well as noninvasive evaluation of vascular endothelial function using a peripheral arterial tonometry apparatus (EndoPAT2000, Itamar Medical Ltd, Caesarea, Israel).
The primary endpoint is the relationship between RHI and 1,5-AG, and secondary endpoints are the relationships of vascular endothelial function (RHI) with HbA1c, IRI, homeostasis model of assessment insulin resistance (HOMA-IR), lipid metabolism, and blood pressure.

Management information
Registered date
2014 Year 03 Month 12 Day
Last modified on
2014 Year 11 Month 15 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015317

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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