臨床研究等提出・公開システム

Date of registration	April. 29, 2023
Last modified on	April. 29, 2023
Trial ID	jRCT1030230057

Scientific Title	Elucidation of the association between sarcopenia and accumulated risks of cerebrovascular disease and its predictive factors in patients with type 2 diabetes mellitus (S-ROAD2 study)
Public Title	Elucidation of the association between sarcopenia and accumulated risks of cerebrovascular disease and its predictive factors in patients with type 2 diabetes mellitus (S-ROAD2 study)

Contact for Scientific Queries	Name	Kusakabe Toru
	Affiliation	National Hospital Organization Kyoto Medical Center
	Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, Kyoto
	Telephone	+81-756419161
	E-mail	kusakabe@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Kusakabe Toru
	Affiliation	National Hospital Organization Kyoto Medical Center
	Address	1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto, Kyoto
	Telephone	+81-756419161
	E-mail	kusakabe@kuhp.kyoto-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Oct. 15, 2021
Actual date of first enrollment		Oct. 15, 2021
Target sample size		450
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who satisfy all of the following criteria. (1) Type 2 diabetes (2) Lower age limit: 20 years old (3) Gender: male and female (4) Outpatients visiting hospitals of the National Hospital Organization (5) Patients who have provided written informed consent
	Exclusion Criteria	Patients who fall under any of the following criteria. (1) Patients with AST or ALT above 100 U/L (2) Patients with Cre above 3.0 mg/dL (3) Female patients who are suspected of being pregnant or pregnant (4) Patients with previous history of angioplasty and bypass surgery, history of hospitalization for heart failure treatment within the past one year (5) Patients with cancer with a history or treatment within five years (6) Patients taking corticosteroids (7) Patients with defects in their limbs (8) Patients wearing pacemakers (9) Patients judged by the investigator/projectleader to be ineligible for other reasons
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 2 diabetes
Health Condition(s) Keyword		Type 2 diabetes, Sarcopenia, Cardiovascular disease
Health Condition(s) Code		D003924
Primary Outcome(s)		Multiple CVD risks (number of complications of diabetes, dyslipidemia, and hypertension)
Secondary Outcome(s)		Phase angle Sarcopenia evaluation indices Obesity evaluation indices Glucose metabolism indices Lipid metabolism indices Blood pressure indices All-cause mortality and CVD events

Primary Sponsor	National Hospital Organization

Source of Monetary Support	National Hospital Organization
Secondary Sponsor	Not applicable

Name of Certified Review Board	Central Ethical Review Committee for Clinical Research of National Hospital Organization
Address	2-5-21 Higashigaoka, Meguro-ku, Tokyo
Approval Status	Approval
Date of approval	Oct. 15, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none