Status:
ACTIVE_NOT_RECRUITING
Building Lipedema Research Resources
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Lipedema
Eligibility:
FEMALE
18-80 years
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 misdiagnos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06180850
Start Date
February 23 2024
End Date
October 1 2026
Last Update
December 30 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203