UMIN-CTR Clinical Trial

Basic information
Public title	Acute effects of the sodium glucose transporter (SGLT) -2 inhibitors,Dapagliflozin, on Hemorheology,Leukocyte Activation and Oxidative Stress in type 2 diabetes.
Acronym	Acute effects of the sodium glucose transporter (SGLT) -2 inhibitors on Hemorheology in type 2 diabetes
Scientific Title	Acute effects of the sodium glucose transporter (SGLT) -2 inhibitors,Dapagliflozin, on Hemorheology,Leukocyte Activation and Oxidative Stress in type 2 diabetes.
Scientific Title:Acronym	Acute effects of the sodium glucose transporter (SGLT) -2 inhibitors on Hemorheology in type 2 diabetes
Region	Japan

Condition
Condition	Type2 Diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The SGLT-2 inhibitor is expected to have a hypoglycemic effect and furthermore a cardiovascular event inhibitory action. However, as a side effect of SGLT-2 inhibitor, urine sugar and urine volume increase, there is concern that increase of urologic infection and decrease of blood fluidity due to dehydration are caused. According to the data of clinical trials so far, it was reported that hematocrit increased by about 2% before and 2 months after SGLT 2 inhibitor administration, but no research report accurately evaluated on blood fluidity and leukocyte activation. The purpose of this study is to clarify blood fluidity of dapagliflozin administration, acute effect on leukocyte activation (deformability and adhesion ability) and oxidative stress.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Whole blood transit time and the difference from baseline at 48h after Dapagliflozin treatment, as assessed using microchannel array flow analyzer equipped with BK7-7-7D chip.nowo
Key secondary outcomes	a)Leukocyte activation (adhesive leukocyte count as determined using the MC-FAN with DKAMCM1-60-7-4.5Denrollment b)Hs-CRP C)Oxidative stress as determined by the d-ROMs test d)Complete blood count

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The group of Dapagliflozin 5mg treatment.
Interventions/Control_2	The group of standard treatment(other than SGLT-2 inhibitor treatment)
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(a)Type 2 diabetes patients with HbA1c>7.0% (b)Diabetic nephropathy stage<4
Key exclusion criteria	(a) Patients with type 1 diabetes mellitus (b) Patients with a medical history of hypersensitivity to any of the ingredients of dapagliflozin (c) Patients with severe ketosis or diabetic coma or pre-coma (d) Patients who have severe infection, are pre- or postoperative, or have sustained serious trauma (e) Patients with severe impaired liver function (f) Patients who are susceptible to dehydration (g) Patients with urinary tract infection or genital infection (h) Patients with a history of cerebrovascular disease within the last 3 months (i) Women who are pregnant or breastfeeding or who may be pregnant (j) Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 mL (k) Patients on warfarin or a novel oral anticoagulant (NOAC) (dabigatran, rivaroxaban, edoxaban, or apixaban) (l) Patients otherwise deemed to be unsuitable for the clinical study by investigators
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Nakatani
Organization	Dokkyo Medical University Nikko Medical Center
Division name	Diabetes and Endcrinology
Zip code	3212593
Address	Takatoku 632, Nikkoshi , Tochigi-Ken
TEL	0288-76-1515
Email	yu-naka@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Nakatani
Organization	Dokkyo Medical University Nikko Medical Center
Division name	Diabetes and Endcrinology
Zip code	3212593
Address	Takatoku 632, Nikkoshi , Tochigi-Ken
TEL	0288-76-1515
Homepage URL
Email	yu-naka@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University Nikko Medical Center
Institute
Department

Funding Source
Organization	Dokkyo Medical University Nikko Medical Center
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	Dokkyo Medical University Nikko Medical Center
Address	Takatoku632,Nikko,Tochigi
Tel	0288761515
Email	yu-naka@dokkyomed.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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 14 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	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 14 Day
Last modified on	2019 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028569