UMIN-CTR Clinical Trial

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
Email	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
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Konoecho, Yoshida, Sakyo-ku Kyoto
Tel	075-753-4680
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026978