LipedemaBRRNCT06180850
Building Lipedema Research Resources
An observational study of Lipedema, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2024to 16 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with or without lipedema
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
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
- Medical subject headings
- Lipedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Participants with lipedema | |
| Controls | Participants without lipedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will measure plasma concentrations of CD8A.
Measured: 1 day
We will measure plasma concentrations of high-sensitivity C-reactive protein.
Measured: 1 day
Secondary outcomes (3)
We will measure the 6-minute walk test.
Measured: 1 day
We will measure the four-meter gait speed test.
Measured: 1 day
We will measure the hand grip strength test.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start23 Feb 2024
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron W. Aday, MD, MSc, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180850
- Sponsor's protocol ID
- 212427
- Acronym
- BRR
- Status last verified
- May 2026
- First submitted
- 12 Dec 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Lipedema Research Resources
- ClinicalTrials.gov ID
- NCT06180850
- Acronym / sponsor ID
- BRR / 212427
- Conditions
- Lipedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Participants with lipedema |
| Controls | – | –Participants without lipedema |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with or without lipedema
Key inclusion criteria (23 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
We will measure plasma concentrations of CD8A.
Time frame: 1 day
We will measure plasma concentrations of high-sensitivity C-reactive protein.
Time frame: 1 day
3 secondary outcomes
We will measure the 6-minute walk test.
Time frame: 1 day
We will measure the four-meter gait speed test.
Time frame: 1 day
We will measure the hand grip strength test.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We will measure plasma concentrations of CD8A. (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.