Building Lipedema Research Resources

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Dec 21, 2023

Keywords

ClinConnect Summary

This clinical trial is focused on understanding a condition called lipedema, which affects many women and is often confused with obesity. Lipedema is characterized by an unusual buildup of fat in the legs and can cause pain and swelling. Researchers aim to create a special collection of samples (called a biorepository) from women with and without lipedema. This will help identify specific markers that can distinguish lipedema from obesity and deepen our understanding of the disease. The ultimate goal is to improve prevention and early treatment options for those affected.

Women aged 18 to 80 who have a formal diagnosis of lipedema or those without the condition may participate in this study. However, there are some exclusions, such as pregnant women, those with certain medical conditions, or individuals who cannot communicate effectively with the researchers. Participants can expect to provide samples and undergo tests to help researchers learn more about lipedema. This study is important because it addresses a significant gap in understanding a condition that impacts many women’s lives.

Gender

FEMALE

Eligibility criteria

• 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