UMIN-CTR Clinical Trial

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
Email	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
Email	furuya19870818@gmail.com

Sponsor
Institute	Dokkyo Medical University Nikko Medical Center,
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051881