Building Lipedema Research Resources
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- We will measure plasma concentrations of CD8A.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
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
Arms & Interventions
Cases
Participants with lipedema
Controls
Participants without lipedema
Outcomes
Primary Outcomes
We will measure plasma concentrations of CD8A.
Time Frame: 1 day
We will measure plasma concentrations of high-sensitivity C-reactive protein.
Time Frame: 1 day
Secondary Outcomes
- We will measure the hand grip strength test.(1 day)
- We will measure the four-meter gait speed test.(1 day)
- We will measure the 6-minute walk test.(1 day)
Investigators
Aaron W. Aday, MD, MSc
Assistant Professor of Medicine
Vanderbilt University Medical Center