An observational study in Lipedema, sponsored by University of Virginia. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by University of Virginia · Observational
This work will address clinical unmet needs for patients with lipedema using advanced magnetic resonance imaging (MRI) methods, in sequence with portable clinical tools, by testing fundamental hypotheses regarding potential screening methods, lymphatic therapy, and vascular dysfunction in patients with lipedema.
Lipedema is a disease marked by disproportionate subcutaneous adipose tissue (SAT) accumulation in the lower extremities that is accompanied by somatic pain and edema. Importantly, lipedema is commonly misdiagnosed as obesity and has been estimated to affect a high 11% of women. However, symptoms are refractory to diet, exercise, and other interventions for obesity leading to a mean delayed diagnosis of 22 years, high physical morbidity, and lifelong distress. Despite growing awareness of lipedema as a distinct clinical entity and a recent call to action for lipedema research, fundamental gaps persist in knowledge regarding both disease mechanisms and treatment options for this debilitating disease.
Over the past four years, multi-disciplinary study from investigators in radiology, vascular medicine, and physical therapy has demonstrated that lipedema has distinct characteristics from obesity. Using whole-body fat-and-water MRI, lipedema is characterized by a 42% higher lower-extremity SAT deposition compared to BMI-matched females without lipedema (p\<0.001). Using noninvasive sodium MRI technologies, skin sodium is also elevated in patients with lipedema compared to controls (14.9±2.9 vs. 11.9±2.0 mmol/L, p=0.01) in the lower extremities, but not upper extremities. Importantly, skin sodium decreases following 6-weeks of lymphatic stimulation by complete decongestive therapy (CDT) in preliminary study of patients with lipedema. These tissue signatures are consistent with those of patients with known lymphatic insufficiencies (i.e., secondary lymphedema). Recent findings of elevated arterial perfusion and inflammatory profiles in lipedema raise significant questions about how blood and lymphatic circulation are involved in lipedema.
The critical barrier to interrogating these systems, and more broadly addressing clinical unmet needs for evidence-based therapies for patients with lipedema, is that noninvasive lymphatic imaging strategies are traditionally underdeveloped. To address this barrier, non-tracer based MR lymphangiography is capable of visualizing lymphatic dilation and stasis in unilateral lymphedema, and similar features of lymphatic insufficiency are observed in the lower extremities of patients with lipedema.
This study will apply these MRI tools together with standard clinical tools to test the following hypotheses:
Hypothesis 1A: Ultrasound can be used as an accessible alternative to MRI for measuring subcutaneous fat deposition to distinguish lipedema from obesity.
Hypothesis 1B: Ultrasound measurement of fat deposition together with bedside tools for measuring water deposition have improved ability than ultrasound alone for distinguishing lipedema from controls.
Hypothesis 2: Tissue sodium is reduced following CDT in the lower extremities, but not in the untreated upper extremities, of patients with lipedema consistent with improved patient-reported outcomes.
Hypothesis 3: Lymphatic flow velocity is reduced, while arterial blood flow is elevated, in the legs of patients with lipedema compared to controls.
78 studies on the registry are indexed under Lipedema; 28 are open to participants now.
This study's planned enrollment of 110 is above the median of 90 across 40 observational studies indexed under Lipedema.
Browse Lipedema studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study Population:
The investigators will recruit adults with and without lipedema
Exclusion Criteria:
Also excluded are subjects incapable of giving informed written consent:
* Participants with lipedema * Biologically Female * Age range = 18-80 years * BMI range = 18 to 40 kg/m2 * BMI range = 18 to 40 kg/m2
* Participants without lipedema * Biologically Female * Age range = 18-80 years * BMI range = 18 to 40 kg/m2
* Participants with lipedema * Biologically Female * Age range = 18-80 years * BMI range = 18 to 40 kg/m2 * BMI range = 18 to 40 kg/m2
Change in tissue sodium content: quantification of tissue sodium content in treated limbs following the completion of therapy
Tissue sodium content (mmol/L) quantified by sodium MRI
Time frame: at baseline and approximately 6 weeks later
Change in lymphedema severity: quantification of lymphatic stasis in treated limbs following the completion of therapy
Lymphatic stasis area (mm\^2) quantified by MR lymphangiography
Time frame: at baseline and approximately 6 weeks later
Baseline tissue sodium content: quantification of tissue sodium in affected limbs
Tissue sodium content (mmol/L) quantified by sodium MRI
Time frame: At baseline
Baseline lymphedema severity: quantification of lymphatic stasis in affected limbs
Lymphatic stasis area (mm\^2) quantified by MR lymphangiography
Time frame: At baseline
Change in limb extracellular water: quantification of limb extracellular water in treated limbs following the completion of therapy
Limb extracellular water (Ohms) estimated by bioimpedance spectroscopy
Time frame: at baseline and approximately 6 weeks later
Change in skin water: quantification of skin water in treated limbs following the completion of therapy
Skin water (percent) estimated by tissue dielectric probe
Time frame: at baseline and approximately 6 weeks later
Change in skin elasticity: quantification of skin elasticity in treated limbs following the completion of therapy
Skin elasticity (Newtons) quantified by fibrometer
Time frame: at baseline and approximately 6 weeks later
Baseline limb extracellular water: quantification of limb extracellular water in affected limbs
Limb extracellular water (Ohms) estimated by bioimpedance spectroscopy
Time frame: At baseline
Baseline skin water: quantification of skin water in affected limbs
Skin water (percent) estimated by tissue dielectric probe
Time frame: At baseline
Baseline skin elasticity: quantification of skin elasticity in affected limbs
Skin elasticity (Newtons) quantified by fibrometer
Time frame: At baseline
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University of Virginia