UMIN-CTR Clinical Trial

Basic information
Public title	A study of prevalence and developing mechanisms of insulin-derived amyloidosis in insulin-treated patients with diabetes
Acronym	A study of insulin-derived amyloidosis
Scientific Title	A study of prevalence and developing mechanisms of insulin-derived amyloidosis in insulin-treated patients with diabetes
Scientific Title:Acronym	A study of insulin-derived amyloidosis
Region	Japan

Condition
Condition	Diabetes mellitus
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To elucidate the prevalence and developing mechanisms of insulin-derived amyloidosis
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of insulin-derived amyloidosis
Key secondary outcomes	Risk factors for incidence

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	To screen amyloidosis at the insulin-injection site by a MRI scan. The MRI scan is performed once in a patient.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients who have been using insulin for six months or more 2) Written informed consent is obtained
Key exclusion criteria	1) Contraindication to MRI
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Terumasa Middle name Last name Nagase
Organization	Tokyo Medical University Ibaraki Medical Center
Division name	Department of Metabolism and Endocrinology
Zip code	3000395
Address	3-20-1 Chuou, Ami, Ibaraki
TEL	029-887-1161
Email	tnagase@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Terumasa Middle name Last name Nagase
Organization	Tokyo Medical University Ibaraki Medical Center
Division name	Department of Metabolism and Endocrinology
Zip code	3000395
Address	3-20-1 Chuou, Ami, Ibaraki
TEL	029-887-1161
Homepage URL
Email	tnagase@tokyo-med.ac.jp

Sponsor
Institute	Department of Metabolism and Endocrinology, Tokyo Medical University Ibaraki Medical Center
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical University Ibaraki Medical Center Ethics Committee
Address	3-20-1 Chuou, Ami, Ibaraki
Tel	029-887-1161
Email	t-taka@tokyo-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科大学茨城医療センター（茨城県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date	2016 Year 02 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 15 Day
Last modified on	2022 Year 02 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024158