臨床研究等提出・公開システム

Date of registration	May. 12, 2026
Last modified on	May. 13, 2026
Trial ID	jRCT1030260124

Scientific Title	Association between gallstone prevalence and ultrasonographic and laboratory findings in patients with diabetes mellitus
Public Title	Study on the relationship between gallstones and ultrasonographic and blood test findings in patients with diabetes

Completion date	May. 11, 2026
Result actual enrolment	80
Baseline Characteristics	31patients with diabetes mellitus and 49patients without diabetes mellitus were included(mean age:66.3years;40males and 40females).Gallbladder arterial blood flow,age,BMI,sex,hypertention,dyslipidemia,glucose,HbA1c,AST,ALT,ALP,HDLcholesterol and LDL cholesterolwere evaluated.
Participant flow	Case selection and data collection were completed,and date analysis was finalized.
Adverse events	No adverse events related to this study were observed.
Outcome measures	No significant difference in gallstone prevalence was observed between the diabetes melitus(DM) and non-DM groups(p=0.519). Regarding gallbladder arterial blood flow,the DM group showed significaantly lower EDV(p<0.02) and higher RI(p<0.0001). In addition,RI showed positive correlations with glucose and HbA1c levels(p=0.037 and p=0.016,respectively).
Brief summary	No significant difference in gallstone prevalence was observed between the DM and non-DM groups. The DM group showed significaantly lower EDVand higher RI values in gallbladder arterial blood flow. RI was positively correlated with glucose and HbA1c levels.
Date of posting of results summaries	June. 27, 2026
Date of the first journal publication of results	June. 27, 2026

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1030260124

Contact for Scientific Queries	Name	Suzuki Daisuke
	Affiliation	Showa Medical University Fujigaoka Hospital
	Address	1-30 Fujigaoka,Aoba-ku,Yokohama,Kanagawa,Japan
	Telephone	+81-45-974-6535
	E-mail	daisuke-s@cmed.showa-u.ac.jp
Contact for Public Queries	Name	Suzuki Daisuke
	Affiliation	Showa Medical University Fujigaoka Hospital
	Address	1-30 Fujigaoka,Aoba-ku,Yokohama,Kanagawa,Japan
	Telephone	+81-45-974-6535
	E-mail	daisuke-s@cmed.showa-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 12, 2026
Target sample size		80
Study Type		Observational
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	Patients who underwent abdominal ultrasonography at Fujigaoka Hospital,Showa Medical University,between November 5, 2024 and August 23,gallbladder arterial blood flow was feasible.
	Exclusion Criteria	Patients undergoing dialysis or those with gallbladder disease,excluding gallstones and gallbladder polyps.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Diabetes mellitus and gallstones
Intervention(s)		No intervention
Primary Outcome(s)		Association between gallstone presence and gallbladder arterial blood flow parameters (PSV,EDV,and RI)
Secondary Outcome(s)		gallbladder arterial blood flow parameters and laboratory findings(glucose,HbA1c,AST,ALT,ALP,HDL cholesterol,LDL-cholesterol),and patient characteristics(age,BMI,sex,hypertention,and dyslipidemia)

Primary Sponsor	None

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Showa Medical University Fujigaoka Hospital Ethics Committee
Address	1-5-8 Hatanodai,Shinagawa-ku,Tokyo,Japan, Tokyo
Telephone	+81-3-3784-8129
E-Mail	ura-ec@ofc.showa-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 17, 2025

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 27, 2026	(this page)	Changes
1	May. 12, 2026	Detail

List of change history