UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021027 |
|---|---|
| Receipt number | R000024158 |
| Scientific Title | A study of prevalence and developing mechanisms of insulin-derived amyloidosis in insulin-treated patients with diabetes |
| Date of disclosure of the study information | 2016/02/15 |
| Last modified on | 2022/02/24 16:20:24 |
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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
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
tnagase@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Metabolism and Endocrinology, Tokyo Medical University Ibaraki Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024158
