Screening for disease progression by measuring lower limb circumference in diabetic patients.

Screening for disease progression by measuring lower limb circumference in diabetic patients. - Screening for disease progression by measuring lower limb circumference in diabetic patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045445

Enrollment

150

Registered

2021-09-10

Start date

2021-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus Arteriosclerosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible patients are outpatients undergoing treatment for type II DM.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactTOMOKI furuya

Dokkyo Medical University Nikko Medical Center, Department of Cardiovascular Medicine and Nephrology,

furuya19870818@gmail.com0288-76-1515

Outcome results