Building Lipedema Research Resources

NCT ID: NCT06180850

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-23
• Study Completion Date: 2026-10-01

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.

Conditions

Lipedema

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cases

Participants with lipedema

No interventions assigned to this group

Controls

Participants without lipedema

No interventions assigned to this group

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Aaron W. Aday, MD, MSc

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

212427

Identifier Type: -

Identifier Source: org_study_id