UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The relationship between glycemic variability and baroreflex sensitivity in type 2 diabetic patients
Title of the study (Brief title)	Jikei tsuruoka glycemic variability and baroreflex sensitivity study
Region	Japan

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

Objectives
Narrative objectives1	To verify the relationship between glycemic variability and baroreflex sensitivity in type 2 diabetic patients.
Basic objectives2	Others
Basic objectives -Others	To verify relationship between intima media thickness of the carotid artery and baroreflex sensitivity in type 2 diabetic patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Coefficient of variation for glycemic variability and baroreflex sensitivity
Key secondary outcomes	･Standard deviation for glycemic variability and baroreflex sensitivity ･Mean amplitude of glycemic excursions for glycemic variability and baroreflex sensitivity ･Fasting plasma glucose and baroreflex sensitivity ･HbA1c and baroreflex sensitivity ･Intima media thickness of the carotid artery and baroreflex sensitivity ･Flow mediated dilation and baroreflex sensitivity

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	･Hospitalized type 2 diabetic patients
Key exclusion criteria	･having arrhythmia ･receiving non-dihydropyridine calcium channel blockers ･receiving digitalis ･receiving antipsychotics ･having severe renal dysfunction (serum Cr > 2.5 mg/dl) ･having severe liver dysfunction (3 X the upper limit of normal) ･having severe infection, severe trauma, or pre and post operation ･having diabetic ketosis, diabetic coma, or insulin-dependent diabetes mellitus ･being pregnant ･having malignancy ･being unsuitable for participation in the trial for any reason, according to the investigators ･having myocardial infarction, heart failure or cerebral infarction within a half year ･heavy drinker
Target sample size	100

Research contact person
Name of lead principal investigator	Daisuke Matsutani
Organization	The Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Address	3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Email	daisuke19870116@jikei.ac.jp

Public contact
Name of contact person	Daisuke Matsutani
Organization	The Jikei University School of Medicine
Division name	Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine
Address	3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	daisuke19870116@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Selt funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 28 Day
Anticipated trial start date	2017 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The prospective study

Management information
Registered date	2017 Year 02 Month 01 Day
Last modified on	2018 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029849