UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045445 |
|---|---|
| Receipt number | R000051881 |
| Scientific Title | Screening for disease progression by measuring lower limb circumference in diabetic patients. |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2021/09/10 14:11:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Screening for disease progression by measuring lower limb circumference in diabetic patients.
Acronym
Screening for disease progression by measuring lower limb circumference in diabetic patients.
Scientific Title
Screening for disease progression by measuring lower limb circumference in diabetic patients.
Scientific Title:Acronym
Screening for disease progression by measuring lower limb circumference in diabetic patients.
Region
| Japan |
Condition
Condition
diabetes mellitus
Arteriosclerosis
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the usefulness of the evaluation of the maximum circumference of the thigh and lower leg in screening for disease progression in patients with diabetes mellitus (DM).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint: Association between femoral leg circumference ratio and DM pathological parameters in DM patients.
Factor analysis was performed using regression analysis with the femoral-femoral circumference ratio as the dependent variable.
Thigh-to-lower leg circumference ratio is the ratio of lower leg circumference to thigh circumference.
Key secondary outcomes
Secondary endpoints: Change from baseline in lower extremity circumference at 12 to 15 months.
Basic information: sex, age, disease, medication status.
Body composition (body weight, body water content, muscle mass, body fat content, body fat percentage, basal metabolic rate, visceral fat level, BMI)
Vascular index: ABI, PWV
Muscle output: knee extensor strength, ankle plantar flexor strength
Blood test data: HbA1C
From the above, DM-related items are defined as HbA1c, DM duration, PWV, and ABI. The methods of measurement are described in the following sections.
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
Eligible patients are outpatients undergoing treatment for type II DM.
Key exclusion criteria
Patients with musculoskeletal disorders of the lower extremities (not excluded if there is no swelling in the lower extremities), amputees, patients with obvious paralysis due to central nervous system disorders, patients with arteriosclerosis obliterans, patients with malignant neoplasms, pregnant women or women suspected of pregnancy, and patients with intracorporeal devices such as cardiac pacemakers.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | TOMOKI |
| Middle name | |
| Last name | furuya |
Organization
Dokkyo Medical University Nikko Medical Center,
Division name
Department of Cardiovascular Medicine and Nephrology,
Zip code
321-2593
Address
632 Takatoku, Nikko-city, Tochigi, Japan
TEL
0288-76-1515
furuya19870818@gmail.com
Public contact
Name of contact person
| 1st name | TOMOKI |
| Middle name | |
| Last name | furuya |
Organization
Dokkyo Medical University Nikko Medical Center,
Division name
Department of Cardiovascular Medicine and Nephrology,
Zip code
321-2593
Address
632 Takatoku, Nikko-city, Tochigi, Japan
TEL
0288-76-1515
Homepage URL
furuya19870818@gmail.com
Sponsor or person
Institute
Dokkyo Medical University Nikko Medical Center,
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency (JST)
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
Dokkyo Medical University Nikko Medical Center,
Address
632 Takatoku, Nikko-city, Tochigi, Japan
Tel
0288-76-1515
furuya19870818@gmail.com
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
| 2021 | Year | 09 | Month | 10 | 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
128
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
unspecified
Management information
Registered date
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2021 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051881
