Building Lipedema Research Resources

Study Overview
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Brief Summary
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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.

Official Title
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Building Lipedema Research Resources

Conditions
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Lipedema

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Participants with lipedema | |
| Controls<br>Participants without lipedema | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will measure plasma concentrations of CD8A. |  | 1 day | 
| We will measure plasma concentrations of high-sensitivity C-reactive protein. |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time 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 |