跳至主要内容
临床试验/NCT07536646
NCT07536646已完成不适用

Abdominal and Lower Extremity Adipose Tissue Elasticity in Patients With Lipedema: A Shear Wave Elastography Study

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2026年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
1
主要终点
Tissue elasticity, as measured by shear-wave elastography (SWE)

研究概览

简要总结

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.

详细描述

Lipedema is a disorder characterized by abnormal bilateral fat deposition in the upper and lower extremities, typically beginning at puberty and predominantly affecting women. Its prevalence in the female population is estimated to be approximately 11%. The condition primarily involves the extremities, while the trunk, hands, and dorsum of the feet are typically spared. It has a genetic predisposition and is influenced by hormonal factors. Despite being relatively common, lipedema is frequently overlooked in daily clinical practice. Therefore, accurate clinical recognition of the disease is essential. In the differential diagnosis, it is often confused with obesity, venous insufficiency, and lymphedema. The main symptoms reported by patients with lipedema include pain, tenderness, and easy bruising.

Previous imaging studies using Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) have demonstrated thickening of the subcutaneous tissue without muscle edema, along with fluid infiltration within adipose tissue.

Ultrasonography (US) provides rapid and reliable diagnosis for many musculoskeletal lesions. Due to its ease of use, absence of radiation, and cost-effectiveness, it has become a preferred modality in musculoskeletal imaging. Elastography techniques vary depending on the method of compression, tissue displacement characteristics, and image acquisition techniques. The main types used in clinical practice include strain (compression) elastography, acoustic radiation force, shear wave elastography (SWE), and transient elastography. In addition to providing morphological information, SWE allows quantitative measurement of tissue elasticity and offers valuable insights into mechanical properties related to degeneration, injury, and healing.

This technology represents an ultrasound-based counterpart of manual palpation used by clinicians for tissue characterization. SWE is one of the ultrasound elastography techniques that utilizes shear wave speed (SWS) to assess tissue stiffness. During real-time B-mode ultrasonography, localized transient displacements in the tissue are generated by short-duration acoustic push pulses, producing shear waves. The propagation speed of these waves (SWS) is then recorded.

Measurements can be expressed in meters per second (m/s) or kilopascals (kPa), depending on the system. The square root of tissue elasticity is proportional to SWS, which directly correlates with tissue stiffness. This implies that stiffer tissues allow faster propagation of shear waves. Extracellular matrix components, particularly fibrotic deposits such as collagen, are the primary determinants of tissue stiffness. Ultrasound elastography has been established as an excellent diagnostic modality for conditions such as liver fibrosis, breast cancer, and thyroid cancer. In the field of musculoskeletal medicine, numerous studies have been conducted since the early 1990s, and its clinical application has increased in recent years .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

lipedema group

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

干预措施: Shearwave elastography (Diagnostic Test)

control group

healty controls

干预措施: Shearwave elastography (Diagnostic Test)

结局指标

主要结局

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

时间窗: 1 day

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

次要结局

  • Tissue elasticity, as measured by shear-wave elastography (SWE)(1 day)

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Abdominal and Lower Extremity Adipose Tissue... | 临床试验