臨床研究等提出・公開システム

Date of registration	Mar. 14, 2023
Last modified on	Mar. 14, 2023
Trial ID	jRCT1050220190

Scientific Title	Effects of SGLT2 inhibitors on appetite in patients with type 2 diabetes
Public Title	Effects of SGLT2 inhibitors on appetite in patients with type 2 diabetes

Contact for Scientific Queries	Name	Nin Kazuko
	Affiliation	Graduate School of Medicine Kyoto University
	Address	53 Shogoin-kawahara-cho, Sakyoku, Kyoto
	Telephone	+81-75-751-3946
	E-mail	nin@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Ishikawa Keiko
	Affiliation	National Cerebral and Cardiovascular Center Hospital
	Address	6-1 Shinmachi, Kishibe, Suita-shi, Osaka
	Telephone	+81-6-6170-1070
	E-mail	ishikawa.keiko@ncvc.go.jp

Recruitment status	Pending

Anticipated date of first enrollment		Mar. 14, 2023
Target sample size		58
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) Those with a diagnosis of type 2 diabetes 2) Persons starting SGLT2 inhibitors 3) Patients between 20 and 85 years of age 4) Patients with renal function eGFR 30 or higher 5) BMI of 18.5 or more
	Exclusion Criteria	1) Those undergoing treatment for cancer 2) Pregnant women 3) Those who are emotionally unstable due to mental illness, etc. and have difficulty participating in the research 4) Those who have difficulty in reading and understanding Japanese 5) Persons with dementia 6) Those who are judged by the attending physician or researcher to be unable to participate in the research.
	Age Minimum	20age old over
	Age Maximum	85age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		type 2 diabetes
Primary Outcome(s)		1) Mean difference in fasting plasma glucose at 24 weeks and at the start of SGLT2 inhibitor 2) Mean difference in total score on the Japanese version of the Power of Food Scale between the start of SGLT2 inhibitor and the 24-week time point
Secondary Outcome(s)		1) Mean difference in body weight at start of SGLT2 inhibitor and at 24 weeks 2) Mean difference in HbA1c between starting SGLT2 inhibitor and 24 weeks 3) Difference in ketone body fraction between starting SGLT2 inhibitor and at 24 weeks 4) Mean difference in calorie intake per day between starting SGLT2 inhibitor and at 24 weeks 5) Mean difference in daily carbohydrate intake between starting SGLT2 inhibitors and at 24 weeks 6) Mean difference in protein intake per day between starting SGLT2 inhibitors and at 24 weeks 7) Mean difference in lipid intake per day between starting SGLT2 inhibitors and at 24 weeks 8) Mean difference in the total score of the Food Craving Inventory for Japanese psychological scale between the start of SGLT2 inhibitor and at 24 weeks 9) Free response on whether there was any change in dietary habits between the start of SGLT2 inhibitors and the 24-week point in time.

Primary Sponsor	Graduate School of Medicine Kyoto University

Primary Sponsor	National Cerebral and Cardiovascular Center Hospital

Secondary Sponsor

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Clinical Research Review Committee, National Cerebral and Cardiovascular Center
Address	6-1 Shinmachi, Kishibe, Suita-shi, Osaka, Osaka
Telephone	+81-6-6170-1070
E-Mail	crb-office@ncvc.go.jp
Approval Status	Approval
Date of approval	Feb. 20, 2023

Name of Certified Review Board	Kyoto University Certified Review Board
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN, Osaka
Telephone	+81-75-753-4680
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval
Date of approval	Feb. 20, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none