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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026537
Receipt No. R000030284
Scientific Title Effect for sodium sensitivity of blood pressure of empagliflozin, sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus
Date of disclosure of the study information 2017/03/29
Last modified on 2017/09/12

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Basic information
Public title Effect for sodium sensitivity of blood pressure of empagliflozin, sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus
Acronym Effect for sodium sensitivity of blood pressure of empagliflozin, sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus
Scientific Title Effect for sodium sensitivity of blood pressure of empagliflozin, sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus
Scientific Title:Acronym Effect for sodium sensitivity of blood pressure of empagliflozin, sodium-glucose co-transporter 2 inhibitor, in patients with type 2 diabetes mellitus
Region
Japan

Condition
Condition type 2 diabetes mellitus
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improvement of sodium sensitivity of blood pressure of empagliflozin
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of sodium sensitivity of blood pressure
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A period of intervention is 16 days.First 4 days, patient have a meal, contain a salt 10 g/day.Next 4days, they have a diet, contain a salt 6g/day.From the following day, they spend same 8days ,taking 10mg of empagliflozin. In each period, we mesure sodium sensitivity from blood, urine examination and blood pressure.
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
80 years-old >
Gender Male and Female
Key inclusion criteria eGFR of patient is more than 45ml/min/1.73m2.
Key exclusion criteria advanced liver disorder.
easy to be dehydrated.
have hypertension, more than 180/110mmHg, or attending physician judged poor control of hypertension.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ichii Mitsuru
Organization Osaka City General Hospital
Division name Department of nephrology and Hypertension
Zip code
Address 2-13-2, Miyakojima-hondori, miyakojima-ku Osaka 534-0021 Japan
TEL 06-6929-1221
Email m41219791@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ichii Mitsuru
Organization Osaka City General Hospital
Division name Department of nephrology and Hypertension
Zip code
Address 2-13-2, Miyakojima-hondori, miyakojima-ku Osaka 534-0021 Japan
TEL 06-6929-1221
Homepage URL
Email m41219791@yahoo.co.jp

Sponsor
Institute Osaka City General Hospital
Institute
Department

Funding Source
Organization Osaka City General Hospital
Organization
Division
Category of Funding Organization Local Government
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
2017 Year 03 Month 29 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 Preinitiation
Date of protocol fixation
2017 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 13 Day
Last modified on
2017 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030284

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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