UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025536 |
|---|---|
| Receipt number | 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 19:59:37 |
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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
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
fwkh7040spring@yahoo.co.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
