臨床研究等提出・公開システム

Japanese

Date of registration	April. 05, 2018
Last modified on	April. 15, 2022
Trial ID	jRCT1090220340

Scientific Title	Association of body composition and daily physical activity with prognosis and metabolic disturbances of patients with diabetes (Association of body composition and daily physical activity with prognosis and metabolic disturbances of patients with diabetes)
Public Title	Association of body composition and daily physical activity with prognosis and metabolic disturbances of patients with diabetes

Contact for Scientific Queries	Investigator Name	Hidetaka Hamasaki
	Investigator Organization	Hamasaki Cliinic
	Address	Nishida 2-21-4, Kagoshima, Kagoshima
	TEL	+81-99-250-3535
	E-mail	hhamasaki78@gmail.com
Contact for Public Queries	Contact Name	Hidetaka Hamasaki
	Contact Organization	Hamasaki Cliinic
	Address	Nishida 2-21-4, Kagoshima, Kagoshima
	TEL	+81-99-250-3535
	E-mail	hhamasaki78@gmail.com

Recruitment Status	COMPLETED

Date of First Enrollment		Feb. 20, 2018
Planned Number of Subjects		900
Nature of Investigation		Observational
Study Design	Description of Trial Design	Prospective cohort study
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with diabetes who are 20 years of age or older.
	Exclusion Criteria	Patients with pacemakers. Patients after extremity amputation. Patients who decline in ADL function and cannot be measured body composition by a bioelectrical impedance analysis.
	Minimum Age	20age old over
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		Diabetes, metabolic diseases
Intervention(s)		Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Death, cardiovascular events, and hospitalizations.
Secondary Outcome(s)		Associations between body composition and metabolic parameters at baseleine. Changes in glycemic control, lipid profile, and blood pressure. Progression of atherosclerosis and diabetic complications.

Primary Sponsor	Hidetaka Hamasaki
Secondary Sponsor

Sources of funding	Hamasaki Clinic

Name of Ethics Committee	Japan Medical Association Ethical Review Board
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Jan. 23, 2018

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Secondary Study ID	Nill Known
Issuer Name

Secondary Study ID	JMA-IIA00340
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	April. 15, 2022	(this page)	Changes
1	April. 05, 2018	Detail

List of change history