臨床研究等提出・公開システム

Date of registration	April. 30, 2026
Last modified on	April. 30, 2026
Trial ID	jRCT1020260003

Scientific Title	Assessment of Postprandial Glucagon Responses Across Diabetes Clusters
Public Title	Assessment of Postprandial Glucagon Responses Across Diabetes Clusters

Contact for Scientific Queries	Name	Shimabukuro Michio
	Affiliation	Fukushima Medical University
	Address	1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan
	Telephone	+81-24-547-1306
	E-mail	dem@fmu.ac.jp
Contact for Public Queries	Name	Nemoto Yuhi
	Affiliation	Fukushima Medical University
	Address	1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan
	Telephone	+81-24-547-1306
	E-mail	y-nemoto@fmu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 30, 2026
Target sample size		120
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. Participants enrolled in Group 1 of the comprehensive study on metabolic syndrome, chronic complications of diabetes, and factors related to prognosis (Fukushima Medical University IRB No. 29118), who provided written informed consent between April 2018 and February 2023 and have been regularly attending the outpatient clinic of the Department of Diabetes, Endocrinology and Metabolism at Fukushima Medical University since February 2026. 2. Participants enrolled in Group 2 of the comprehensive study on metabolic syndrome, chronic complications of diabetes, and factors related to prognosis: genome-wide association analysis (Fukushima Medical University IRB No. 2022-028), who provided written informed consent since March 2023 and are currently attending the outpatient clinic of the Department of Diabetes, Endocrinology and Metabolism at Fukushima Medical University.
	Exclusion Criteria	Participants in Groups 1 and 2 who do not provide consent to participate in this study, or who withdraw consent after enrollment.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Diabetes mellitus
Intervention(s)		Participants will ingest 10 g of BCAA powder dissolved in 350-450 mL of water. Blood samples (5 mL each) will be collected before ingestion and at 30, 60, and 120 minutes after ingestion.
Health Condition(s) Code		D003920
Intervention(s) Code		D008019
Primary Outcome(s)		Change in serum glucagon levels before and after BCAA loading

Source of Monetary Support	Japan Society for the Promotion of Science

Source of Monetary Support	The Japan Diabetes Society

Name of Certified Review Board	Fukushima Medical University Certified Review Board
Address	1 Hikarigaoka, Fukushima City, Fukushima 960-1295, Japan, Fukushima
Telephone	+81-24-547-1825
E-Mail	fmucrb@fmu.ac.jp
Approval Status	Approval
Date of approval	April. 27, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none