Visualizing Vascular Mechanisms of Lipedema

NCT05464927 | Active Not Recruiting

• 3 other identifiers: 3021971R01HL157378-01210181
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lipedema

Keywords

MRI; Sodium; Adipose Tissue; fibrosis; lipedema

Outcome Measures

Primary Outcomes (10)

• 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

  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

  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

  At baseline

• Baseline lymphedema severity: quantification of lymphatic stasis in affected limbs

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

  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

  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

  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

  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

  At baseline

• Baseline skin water: quantification of skin water in affected limbs

  Skin water (percent) estimated by tissue dielectric probe

  At baseline

• Baseline skin elasticity: quantification of skin elasticity in affected limbs

  Skin elasticity (Newtons) quantified by fibrometer

  At baseline

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study Population: The investigators will recruit adults with and without lipedema

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples obtained during the course of this research will be aliquoted, de-identified and stored in freezers for future analysis.

MeSH Terms

Conditions

Lipedema; Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Rachelle Crescenzi, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 19, 2022
• Study Start: September 1, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)