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NCT Number: NCT05464927

Visualizing Vascular Mechanisms of Lipedema

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.

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Key information

Conditions

Lipedema Connective Tissue Diseases Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with and without lipedema
  • Biologically Female
  • Age range = 18-80 years
  • BMI range = 18 to 40 kg/m2

Exclusion criteria

  • Primary lymphedema
  • Contraindication to 3T MRI
  • Pregnant
  • Severe claustrophobia
  • Inability to provide written, informed consent
  • Active infection anywhere in the body, or open wound on the lower-extremities or at locations for measurement

Also excluded are subjects incapable of giving informed written consent:

  • Subjects who have an inability to communicate with the researcher for any reason
  • Subjects who are non-English speaking who cannot communicate through a translator, or if a translator is not available
  • Subjects who cannot adhere to the experimental protocols for any reason
  • Subjects who have limited mental ability to give informed consent due to mental disability, confusion, or psychiatric disorders
  • Prisoners

Treatment and study plan

Primary outcomes

  1. Change in tissue sodium content: quantification of tissue sodium content in treated limbs following the completion of therapy

    Time frame: at baseline and approximately 6 weeks later

    Tissue sodium content (mmol/L) quantified by sodium MRI

  2. Change in lymphedema severity: quantification of lymphatic stasis in treated limbs following the completion of therapy

    Time frame: at baseline and approximately 6 weeks later

    Lymphatic stasis area (mm^2) quantified by MR lymphangiography

  3. Baseline tissue sodium content: quantification of tissue sodium in affected limbs

    Time frame: At baseline

    Tissue sodium content (mmol/L) quantified by sodium MRI

  4. Baseline lymphedema severity: quantification of lymphatic stasis in affected limbs

    Time frame: At baseline

    Lymphatic stasis area (mm^2) quantified by MR lymphangiography

  5. Change in limb extracellular water: quantification of limb extracellular water in treated limbs following the completion of therapy

    Time frame: at baseline and approximately 6 weeks later

    Limb extracellular water (Ohms) estimated by bioimpedance spectroscopy

  6. Change in skin water: quantification of skin water in treated limbs following the completion of therapy

    Time frame: at baseline and approximately 6 weeks later

    Skin water (percent) estimated by tissue dielectric probe

  7. Change in skin elasticity: quantification of skin elasticity in treated limbs following the completion of therapy

    Time frame: at baseline and approximately 6 weeks later

    Skin elasticity (Newtons) quantified by fibrometer

  8. Baseline limb extracellular water: quantification of limb extracellular water in affected limbs

    Time frame: At baseline

    Limb extracellular water (Ohms) estimated by bioimpedance spectroscopy

  9. Baseline skin water: quantification of skin water in affected limbs

    Time frame: At baseline

    Skin water (percent) estimated by tissue dielectric probe

  10. Baseline skin elasticity: quantification of skin elasticity in affected limbs

    Time frame: At baseline

    Skin elasticity (Newtons) quantified by fibrometer

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Vanderbilt University Medical Center

Registry information

Acronym: VMP

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 19, 2022
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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