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Building Lipedema Research Resources

Building Lipedema Research Resources

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06180850
Acronym
BRR
Enrollment
60
Registered
2023-12-26
Start date
2024-02-23
Completion date
2026-01-16
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lipedema

Brief 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.

Interventions

None listed

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
We will measure plasma concentrations of CD8A.1 day
We will measure plasma concentrations of high-sensitivity C-reactive protein.1 day

Secondary

MeasureTime frame
We will measure the 6-minute walk test.1 day
We will measure the four-meter gait speed test.1 day
We will measure the hand grip strength test.1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026