UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024822 |
|---|---|
| Receipt number | R000026978 |
| Scientific Title | Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2022/07/31 16:59:37 |
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Basic information
Public title
Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes
Acronym
Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes
Scientific Title
Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes
Scientific Title:Acronym
Effect of SGLT2 inhibitor on energy metabolism in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in energy metabolism after administration of SGLT2 inhibitor in patients with type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in hepatocellular adenosine triphosphate (ATP) concentrations from baseline
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT2 innhibitor: once-daily SGLT2 inhibitor (dapagliflozin 5mg) as add-on to the conventional treatment for 1 week.
Interventions/Control_2
Low-carbo diet: low-carbo (40-45%) diet as add-on to the conventional treatment for 1 week.
Interventions/Control_3
Control: conventional (55-60% carbohydrate) diet treatment (control) for 1 week.
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
Inclusion Criteria are type 2 diabetes, age between 20 and 80 years, and BMI>20
Key exclusion criteria
Exclusion criteria are type 1 diabetes, secondary diabetes, severe ketosis, diabetic coma or pre-coma patients, alcoholism, severe depression or other psychological condition, malignancy, viral hepatitis, severe liver dysfunction, abnormal hemoglobinemia, severe infections diseases, pre- or post-surger, severe traumatic injury, contraindication for MRI like having metal pieces embedded in the body, pregnant or lactating woman, renal deficiency(eGFR<45mL/min/1.73m2), history of hypersensitivity to dapagliflozin, and those who are not considered to be suitable by an attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Fujita |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL
075-751-3560
yfujita9@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hospital |
| Middle name | |
| Last name | Kyoto University Hospital |
Organization
General Affairs Division
Division name
Research Promotion Unit
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL
075-751-4899
Homepage URL
trans@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca K.K. and Ono Pharmaceutical CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Konoecho, Yoshida, Sakyo-ku Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2017 | Year | 01 | Month | 01 | 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
| 2016 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 14 | Day |
Last modified on
| 2022 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026978
| 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 |
