UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of glycemic variability on endothelial progenitor cells from peripheral blood of patients with type 1 diabetes
Title of the study (Brief title)	Relation between glycemic variability and endothelial progenitor cells
Region	Japan

Condition
Condition	Diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the influence of glycemic control and variability on number of peripheral blood endothelial progenitor cells in patients with type 1 diabetes.
Basic objectives2	Others
Basic objectives -Others	Comparison to patients with type 2 diabetes and healthy controls
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Correlation between parameters for glycemic variability which is measured by continuous glucose monitoring and number of peripheral blood endothelial progenitor cells
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	1.Measurement of blood glucose level by CGM(Continuous Glucose Monitoring) 2.Taking blood samples
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with type 1 diabetes and type 2 diabetes and healthy controls
Key exclusion criteria	Pregnancy
Target sample size	40

Research contact person
Name of lead principal investigator	Akihisa Imagawa
Organization	Osaka Medical College
Division name	Department of Internal Medicine (I)
Address	2-7 Daigaku-machi, Takatsuki City, Osaka
TEL	072-683-1221
Email	imagawa@osaka-med.ac.jp

Public contact
Name of contact person	Chiharu Tsutsumi
Organization	Osaka Medical College
Division name	Department of Internal Medicine (I)
Address	2-7 Daigaku-machi, Takatsuki City, Osaka
TEL	072-683-1221
Homepage URL
Email	in1299@osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	大阪医科大学附属病院(大阪府)

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 07 Day
Anticipated trial start date	2014 Year 09 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.1007/s13340-017-0335-x
Results
Other related information

Management information
Registered date	2014 Year 09 Month 04 Day
Last modified on	2017 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017523