Building Lipedema Research Resources

Lipedema Clinical Trial

— BRR  

Official title:

Building Lipedema Research Resources

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180850
• Other study ID #: 212427
• Status: Recruiting
• Start date: February 23, 2024
• Est. completion date: October 1, 2026

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Caroline Crush, MSHA
• Phone: 615-421-0243
• Email: caroline.crush[@]vumc.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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
• 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

Related Conditions & MeSH terms

• Lipedema

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We will measure plasma concentrations of CD8A.		1 day
Primary	We will measure plasma concentrations of high-sensitivity C-reactive protein.		1 day
Secondary	We will measure the 6-minute walk test.		1 day
Secondary	We will measure the four-meter gait speed test.		1 day
Secondary	We will measure the hand grip strength test.		1 day