Building Lipedema Research Resources (BRR)

Vanderbilt University Medical Center

Status

Invitation-only

Conditions

Lipedema

Study type

Observational

Funder types

Other

Identifiers

NCT06180850

212427

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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
Taking any anticoagulation or antiplatelet therapy other than aspirin (up to 100 mg daily)
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