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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024822
Receipt No. 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 2018/06/26

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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
Middle name
Last name Yoshihito Fujita
Organization Kyoto University Graduate School of Medicine
Division name Department of Diabetes, Endocrinology and Nutrition
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL 075-751-3560
Email yfujita9@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoto University Hospital
Organization General Affairs Division
Division name Research Promotion Unit
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL 075-751-4899
Homepage URL
Email trans@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

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
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 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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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
2016 Year 11 Month 14 Day
Last modified on
2018 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026978

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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