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OpenTrials
Completed

NCT Number: NCT06180850

Building Lipedema Research Resources

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. We will measure plasma concentrations of CD8A.

    Time frame: 1 day

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

    Time frame: 1 day

Secondary outcomes

  1. We will measure the 6-minute walk test.

    Time frame: 1 day

  2. We will measure the four-meter gait speed test.

    Time frame: 1 day

  3. We will measure the hand grip strength test.

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: BRR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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