Building Lipedema Research Resources

NCT06180850 | Active Not Recruiting

• 1 other identifier: 212427
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• We will measure plasma concentrations of CD8A.

  1 day

• We will measure plasma concentrations of high-sensitivity C-reactive protein.

  1 day

Secondary Outcomes (3)

• 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

Study Arms (2)

Cases

Participants with lipedema

Controls

Participants without lipedema

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with or without lipedema

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A standard blood draw will be acquired. Up to 60 mL will be acquired in a 1-time visit. Urine collection procedures. Tissue punch biopsy taken from the following locations: The peri-umbilical region, right upper inner-thigh, left upper inner-thigh

MeSH Terms

Conditions

Lipedema

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 26, 2023
• Study Start: February 23, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

US (1)