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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024821
Receipt No. R000028569
Scientific Title Acute effects of the sodium glucose transporter (SGLT) -2 inhibitors,Dapagliflozin, on Hemorheology,Leukocyte Activation and Oxidative Stress in type 2 diabetes.
Date of disclosure of the study information 2016/11/14
Last modified on 2018/11/17

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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
Middle name
Last name Nakatani Yuki
Organization Dokkyo Medical University Nikko Medical Center
Division name Diabetes and Endcrinology
Zip code
Address Takatoku 632, Nikkoshi , Tochigi-Ken
TEL 0288-76-1515
Email yu-naka@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nakatani Yuki
Organization Dokkyo Medical University Nikko Medical Center
Division name Diabetes and Endcrinology
Zip code
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
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
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
2018 Year 11 Month 17 Day


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

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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