UMIN-CTR Clinical Trial

Basic information
Public title	Effects of SGLT2 inhibitor on gut microbiota in the patients with type 2 diabetes
Acronym	Effects of SGLT2 inhibitor on gut microbiota in the patients with type 2 diabetes
Scientific Title	Effects of SGLT2 inhibitor on gut microbiota in the patients with type 2 diabetes
Scientific Title:Acronym	Effects of SGLT2 inhibitor on gut microbiota in the 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 investigate the effects of treatment of SGLT2 inhibitor for 3 months on gut microbiota in the patients with type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fecal microbiota
Key secondary outcomes	Body weight and hemoglobin A1c level

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	The patients with type 2 diabetes are treated with 2.5 mg/day luseogliflozin or 5 mg/day dapagliflozin for 3 months
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	Hemoglobin A1c level: 6.5-11.5%
Key exclusion criteria	eGFR: less than 45 mL/min/1.73 m2
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Masataka Middle name Last name Kusunoki
Organization	Nagoya University
Division name	Research Center of Health, Physical Fitness and Sports
Zip code	464-8601
Address	Furo-cho, Chikusa-ku, Nagoya
TEL	052-789-3946
Email	info@tonyo.jp

Public contact
Name of contact person	1st name Masataka Middle name Last name Kusunoki
Organization	Nagoya University
Division name	Research Center of Health, Physical Fitness and Sports
Zip code	464-8601
Address	Furo-cho, Chikusa-ku, Nagoya
TEL	052-789-3946
Homepage URL
Email	info@tonyo.jp

Sponsor
Institute	Akishima Clinic
Institute
Department

Funding Source
Organization	Akishima Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Akishi
Address	4-2-29 Sakae, Naka-ku, Naogya
Tel	052-243-1024
Email	info@tonyo.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	医療法人社団織田会あきしまクリニック（愛知県）

Other administrative information
Date of disclosure of the study information	2022 Year 09 Month 02 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	8
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	2019 Year 07 Month 29 Day
Date of IRB	2019 Year 09 Month 22 Day
Anticipated trial start date	2019 Year 10 Month 14 Day
Last follow-up date	2022 Year 04 Month 30 Day
Date of closure to data entry	2022 Year 07 Month 31 Day
Date trial data considered complete	2022 Year 08 Month 31 Day
Date analysis concluded	2022 Year 12 Month 20 Day

Other
Other related information

Management information
Registered date	2022 Year 09 Month 02 Day
Last modified on	2022 Year 09 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055631