LipedemaVMPNCT05464927
Visualizing Vascular Mechanisms of Lipedema
An observational study of Lipedema, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study Population: The investigators will recruit adults with and without lipedema
Who may be able to join
- Participants with and without lipedema
- Biologically Female
- Age range = 18-80 years
- BMI range = 18 to 40 kg/m2
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
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.
Read the detailed description
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.
- Conditions
- Lipedema
- Keywords
- MRI, Sodium, Adipose Tissue, fibrosis, lipedema
- Medical subject headings
- Lipedema, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants pre CDT | * Participants with lipedema * Biologically Female * Age range = 18-80 years * BMI range = 18 to 40 kg/m2 * BMI range = 18 to 40 kg/m2 | |
| Controls | * Participants without lipedema * Biologically Female * Age range = 18-80 years * BMI range = 18 to 40 kg/m2 | |
| Participants post CDT | * Participants with lipedema * Biologically Female * Age range = 18-80 years * BMI range = 18 to 40 kg/m2 * BMI range = 18 to 40 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: At baseline
Baseline lymphedema severity: quantification of lymphatic stasis in affected limbs
Lymphatic stasis area (mm^2) quantified by MR lymphangiography
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline
Baseline skin water: quantification of skin water in affected limbs
Skin water (percent) estimated by tissue dielectric probe
Measured: At baseline
Baseline skin elasticity: quantification of skin elasticity in affected limbs
Skin elasticity (Newtons) quantified by fibrometer
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Sep 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Rachelle Crescenzi, University of Virginia
- Investigators
- Rachelle Crescenzi, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464927
- Sponsor's protocol ID
- 302197
- Other IDs
- 1R01HL157378-01, 210181
- Acronym
- VMP
- Status last verified
- Apr 2025
- First submitted
- 8 Jul 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualizing Vascular Mechanisms of Lipedema
- ClinicalTrials.gov ID
- NCT05464927
- Acronym / sponsor ID
- VMP / 302197
- Conditions
- Lipedema
- Keywords
- MRI, Sodium, Adipose Tissue, fibrosis, lipedema
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Vanderbilt University Medical Center
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants pre CDT | – | –* Participants with lipedema * Biologically Female * Age range = 18-80 years * BMI range = 18 to 40 kg/m2 * BMI range = 18 to 40 kg/m2 |
| Controls | – | –* Participants without lipedema * Biologically Female * Age range = 18-80 years * BMI range = 18 to 40 kg/m2 |
| Participants post CDT | – | –* Participants with lipedema * Biologically Female * Age range = 18-80 years * BMI range = 18 to 40 kg/m2 * BMI range = 18 to 40 kg/m2 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population: The investigators will recruit adults with and without lipedema
Key inclusion criteria (4 listed)
- Participants with and without lipedema
- Biologically Female
- Age range = 18-80 years
- BMI range = 18 to 40 kg/m2
Key exclusion criteria (12 listed)
- Primary lymphedema
- Contraindication to 3T MRI
- Pregnant
- Severe claustrophobia
- Inability to provide written, informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Baseline tissue sodium content: quantification of tissue sodium in affected limbs
Time frame: At baseline
Tissue sodium content (mmol/L) quantified by sodium MRI
Baseline lymphedema severity: quantification of lymphatic stasis in affected limbs
Time frame: At baseline
Lymphatic stasis area (mm^2) quantified by MR lymphangiography
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
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
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
Baseline limb extracellular water: quantification of limb extracellular water in affected limbs
Time frame: At baseline
Limb extracellular water (Ohms) estimated by bioimpedance spectroscopy
Baseline skin water: quantification of skin water in affected limbs
Time frame: At baseline
Skin water (percent) estimated by tissue dielectric probe
Baseline skin elasticity: quantification of skin elasticity in affected limbs
Time frame: At baseline
Skin elasticity (Newtons) quantified by fibrometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachelle Crescenzi, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.