Active — Not RecruitingNot Applicable

Building Lipedema Research Resources

United States200 participantsStarted 2024-02-23

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 m…

What they're measuring

We will measure plasma concentrations of CD8A.

Timeframe: 1 day

We will measure plasma concentrations of high-sensitivity C-reactive protein.

Timeframe: 1 day

Trial details

NCT IDNCT06180850

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-10-01