Purpose

Lipedema is a disease marked by subcutaneous adipose tissue accumulation in the lower extremities of females that is accompanied by somatic pain and edema. Importantly, lipedema is commonly misdiagnosed as obesity, although it's estimated to affect a high 11% of women. Clinical diagnosis of lipedema requires specialized training not widely available at most major medical centers, and there remains a substantial need for objective tools to distinguish lipedema from obesity. There is a critical need to define specific molecular markers of disease in circulation or at the tissue-level. The purpose of this study is to create, manage, and characterize an innovative lipedema biorepository. The goal of the biorepository will be to better understand disease mechanisms of lipedema and to define specific molecular markers of disease in circulation or at the tissue-level. The long-term purpose of our studies are to help with prevention and early management of lipedema.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants with or without lipedema - Age range = 18-80 years - Participants with lipedema have a formal diagnosis by a physician using criteria in Appendix A of protocol - Female

Exclusion Criteria

Volunteers in the lipedema or control group will be excluded with the following: - Pregnant or breast-feeding - Active infection anywhere in the body, or open wound on the lower-extremities or at locations for ultrasound, bioimpedance, and tissue dielectric measurements - Battery-operated device implanted that cannot be removed for ultrasound, DXA scan, bioimpedance, and tissue dielectric measurements - Primary lymphedema - Uncontrolled diabetes, renal disease, thyroid disease, or hypertension - Hormone dysregulation or another significant clinical condition affecting hormone status as confirmed by clinical co-investigators - Bone metastases - Contrast imaging scan in the previous 7 days - Nuclear medicine scan in previous 3 days - Lumbar spine fusion - Weigh more than 500 lb (226.8 kg) 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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Control
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
Cases Participants with lipedema
Controls Participants without lipedema

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37203
Contact:
Study Coordinator
615-421-0243
caroline.crush@vumc.org

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Caroline Crush, MSHA
615-421-0243
caroline.crush@vumc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.