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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025536
Receipt No. R000029393
Scientific Title Evaluation of appropriate nutrient intake for patients treated with sodium-glucose-cotransporter-2 inhibitor.
Date of disclosure of the study information 2017/01/14
Last modified on 2017/02/13

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Basic information
Public title Evaluation of appropriate nutrient intake for patients treated with sodium-glucose-cotransporter-2 inhibitor.
Acronym Effect of SGLT2 inhibitor on nutrient intake
Scientific Title Evaluation of appropriate nutrient intake for patients treated with sodium-glucose-cotransporter-2 inhibitor.
Scientific Title:Acronym Effect of SGLT2 inhibitor on nutrient intake
Region
Japan

Condition
Condition type2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of dapaglifozin on the change of nutrient intake and body composition in type2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Nutrient intake (at 0.4.12 weeks after administration, estimated by brief-type self-administered diet history questionnaire)
Body composition(at 0.12 weeks after administration, calculated by DEXA)
Key secondary outcomes Fasting plasma glucose,GA,HbA1c
Liver function,renal function,serum keton body, lipid level,serum glucagon,C-peptide
Blood pressure,body weight,etc.

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 administiration of dapagliflozin(5mg/day)
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
30 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Outpatient treatment at our medical center
Key exclusion criteria 1. Patients with hypersensitivity to Dapaglifozin
2. Type1 diabetes
3. Subjects with severe ketosis,diabetic coma or precoma
4. Subjects with severe infection,befor and after surgery or severe injury
5. Pregnancy
6. Past history of acute coronary syndrome
7. Malignancy
8. Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuhide Inoue
Organization Shizuoka General Hospital
Division name Center of Diabetes and endoclinology
Zip code
Address 4-27-1,Kita-Ando,Aoi-ku,Shizuoka,Japan
TEL 054-247-6111
Email tatsuhide-inoue@i.shizuoka-pho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rieko Kosugi
Organization Shizuoka General Hospital
Division name Center of Diabetes and endoclinology
Zip code
Address 4-27-1,Kita-Ando,Aoi-ku,Shizuoka,Japan
TEL 054-247-6111
Homepage URL
Email fwkh7040spring@yahoo.co.jp

Sponsor
Institute Shizuoka General Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 01 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 Completed
Date of protocol fixation
2015 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 25 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 02 Month 14 Day
Date trial data considered complete
2017 Year 02 Month 14 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 05 Day
Last modified on
2017 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029393

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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