Abdominal and Lower Extremity Adipose Tissue Elasticity in Patients With Lipedema

NCT07536646 | Completed

• 1 other identifier: Shearwave study
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Lipedema is a chronic disorder characterized by abnormal bilateral fat deposition in the extremities, predominantly affecting women and typically beginning at puberty. The trunk, hands, and feet are usually spared. Despite its relatively high prevalence, lipedema is frequently underrecognized in clinical practice and is often confused with conditions such as obesity, venous insufficiency, and lymphedema. Patients commonly present with pain, tenderness, and easy bruising. Current imaging methods have demonstrated increased subcutaneous tissue thickness and fluid infiltration in lipedema; however, no imaging modality has yet been established as a definitive diagnostic tool. Shear wave elastography (SWE) is a noninvasive ultrasound-based technique that enables quantitative assessment of tissue stiffness and may provide additional information regarding tissue structure and mechanical properties. In this study, we aim to compare lower extremity subcutaneous tissue stiffness in patients with lipedema and healthy controls using SWE. As a secondary objective, we aim to evaluate abdominal subcutaneous tissue stiffness in patients with lipedema and compare these findings with both lower extremity measurements in the same patients and abdominal measurements in individuals without lipedema.

Conditions

Lipedema

Keywords

shearwave elastography; lipedema; tissue elasticity

Outcome Measures

Primary Outcomes (1)

• Tissue elasticity, as measured by shear-wave elastography (SWE)

  Comparison of tissue elasticity at the specified sites in both legs between patients with lipedema and healthy controls

  1 day

Secondary Outcomes (1)

• Tissue elasticity, as measured by shear-wave elastography (SWE)

  1 day

Study Arms (2)

lipedema group

Women aged ≥18 years with lipedema (stages 1-3)

Diagnostic Test: Shearwave elastography

control group

healty controls

Diagnostic Test: Shearwave elastography

Interventions

Shearwave elastography DIAGNOSTIC_TEST

Tissue elasticity was assessed using shear wave elastography (SWE) by a radiologist with 18 years of experience, using an RS 85 US device (Samsung Medison, Seoul, Korea) with an SL 10-2 linear probe. Patients were examined in the supine position, and a 10-mm layer of high-viscosity gel was applied to minimize compression. Bilateral measurements were obtained from four sites (anterior thigh, pretibial region, lateral leg, and abdomen), with three measurements per site averaged for analysis.

control group; lipedema group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women aged ≥18 years with lipedema (stages 1-3) and healthy controls were included.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged ≥18 years with lipedema (stages 1-3) and healthy controls were included.

You may qualify if:

• Women aged ≥18 years with lipedema (stages 1-3) and healthy controls with adequate cognitive function

You may not qualify if:

• Age \<18 years Lymphedema Edema of cardiac or nephrogenic origin Diabetes mellitus Thyroid dysfunction Oncological diseases Polyneuropathy or radiculopathy Advanced degenerative diseases affecting the extremities Use of antiepileptic or antidepressant drugs within the last 6 months Use of edema-inducing medications (e.g., corticosteroids, calcium channel blockers, gabapentin, pregabalin) Cognitive impairment preventing participation

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Education and Training Hospital

Istanbul, Ataşehir, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Feyza Akan Begoğlu

  Fatih Sultan Mehmet Education and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start: January 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

TU (1)