UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051790 |
|---|---|
| Receipt number | R000058468 |
| Scientific Title | Factors Associated With Thickness of Fascia in Patients With Type 2 Diabetes: A cross-sectional study |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2024/01/22 13:47:31 |
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Basic information
Public title
Factors Associated With Thickness of Fascia in Patients With Type 2 Diabetes: A cross-sectional study
Acronym
Factors Associated With Thickness of Fascia in Patients With Type 2 Diabetes: A cross-sectional study
Scientific Title
Factors Associated With Thickness of Fascia in Patients With Type 2 Diabetes: A cross-sectional study
Scientific Title:Acronym
Factors Associated With Thickness of Fascia in Patients With Type 2 Diabetes: A cross-sectional study
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will analyze the characteristics of fascia in Japanese type 2 diabetes patients, and apply the results to evaluation of diabetic patients' locomotor, exercise therapy, prediction of the occurrence of diabetic foot lesions, and foot care.
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
thickness of myofacsia in the dominant leg (gastrocnemius)
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Outpatients with type 2 diabetes at the research institution
2.Age between 40 and 75
3.Persons who have consented in writing (excluding proxy consenters)
Key exclusion criteria
1.Athletes, bodybuilders
2.History of the following: Charcot joint, congenital or acquired ankle deformity, plantar fasciitis, leg amputation, trauma
3.Neurological diseases other than diabetic neuropathy
4.Steroid users
5.Smoker
6.Significant restriction of movement
7.Malnutrition
8.Those who do not understand or agree with the purpose of the research
9.Persons judged inappropriate by the attending physician, Investigator, or co-investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | YUSUKE |
| Middle name | |
| Last name | HIROTA |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Diabetology,Endocrinology,and Metabolism
Zip code
193-0998
Address
1163 Tatemachi Hachioji Tokyo
TEL
042-665-5611
dmnaika@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Awane |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Diabetology,Endocrinology,and Metabolism
Zip code
193-0998
Address
1163 Tatemachi Haciouji Tokyo
TEL
042-665-5611
Homepage URL
dmnaika@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japanese Non-surgical Orthopedics Society (JNOS)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Institutional Review Board
Address
6-7-1 Nishishinjyuku Shinjyuku Tokyo
Tel
03-3342-6111
IRB@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
医療社団法人 高村内科クリニック（東京）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 01 | 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
| 2023 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2023 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058468
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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