UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037936 |
|---|---|
| Receipt number | R000043234 |
| Scientific Title | Three dimensions mapping of the subcutaneous tissue by using shear wave elastography |
| Date of disclosure of the study information | 2019/09/05 |
| Last modified on | 2023/09/15 16:35:05 |
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Basic information
Public title
Three dimensions mapping of the subcutaneous tissue by using shear
wave elastography
Acronym
Three dimensions mapping of the subcutaneous tissue by using shear
wave elastography
Scientific Title
Three dimensions mapping of the subcutaneous tissue by using shear
wave elastography
Scientific Title:Acronym
Three dimensions mapping of the subcutaneous tissue by using shear
wave elastography
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to quantitate and visualize
the subcutaneous mass constructed at the insulin injection site and to
reveal the character of the mass.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantification of the subcutaneous mass
Key secondary outcomes
Serum insulin level
Measurement of the insulin-related peptides of the mass
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are included
in this study:
1.Patients who use insulin
2.Patients with a subcutaneous mass at the insulin
injection site
Key exclusion criteria
Patients who fall into any of the following criteria are excluded from
participating in the study:
1.Patients with heart failure or medical history of heart failure
2.Patients with medical history of hypersensitivity for the used drug
3.Patients with severe ketosis, diabetic coma or pre-coma
4.Patients with severe liver dysfunction
5.Patients with severe renal dysfunction
6.Patients with serious infectious disease, pre or post-operative state or serious injury
7.Patients during cancer treatment
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Uchino |
Organization
Toho University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
h.uchino@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Uchino |
Organization
Toho University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
h.uchino@med.toho-u.ac.jp
Sponsor or person
Institute
Division of Diabetes, Metabolism and Endocrinology,
Department of Internal Medicine, Toho University Omori
Medical Center
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
(MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University School of Medicine
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan
Tel
03-3762-4151
h.uchino@med.toho-u.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/jdi.13762
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/jdi.13762
Number of participants that the trial has enrolled
7
Results
The shear wave velocity in subcutaneous dystrophic tissue (DT) was significantly higher than that in the control tissue. The proportion of the DT volume was 0.67% and 5.21% for two individuals from the entire abdominal subcutaneous tissue volume. The area under the curve for the subcutaneously injected insulin aspart concentration at the DT sites was lower than that of the control tissue.
Results date posted
| 2023 | Year | 09 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study population comprised four men and three women, with a median age of 64 years. The body mass index was 29.4 kg/m2, and the HbA1c was 7.9%. The duration of diabetes was 22 years, and the duration of insulin therapy was 9 years. All patients had been using insulin analogs for multiple daily insulin injections, and the total daily insulin dose was 64 U/day.
Participant flow
Seven patients who met the inclusion criteria were enrolled in this study. Written informed consent was obtained from all the participants.
Adverse events
Not Applicable.
Outcome measures
The shear wave velocity (SWV) of dystrophic tissue and control (normal subcutaneous tissue)
The proportion of dystrophic tissue
The area under the curve for the subcutaneously injected insulin aspart concentration in both the DT and control tissues
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Long-term, repeated and same site insulin injection leads
to constructing a subcutaneous mass. However, details of
the mass are not known for sure.
In order to collect data about patients with the
subcutaneous mass, we enroll 7 patients who are able to
meet the inclusion criteria.
Management information
Registered date
| 2019 | Year | 09 | Month | 05 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043234
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| Registered date | File name |
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