UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024821 |
|---|---|
| Receipt number | 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 | 2019/11/17 18:16:46 |
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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 | 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
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
yu-naka@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028569
