ClinicalTrials.gg
CompletedNCT06180850BRRUpdated Jun 2, 2026

Building Lipedema Research Resources

An observational study in Lipedema, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.

Sponsored by Vanderbilt University Medical Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 80 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Lipedema

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03

In context

Lipedema

85 studies on the registry are indexed under Lipedema; 32 are open to participants now.

This study's enrollment of 60 is below the median of 90 across 42 observational studies indexed under Lipedema.

Browse Lipedema studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.

Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants with or without lipedema

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: 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
  • 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 due to mental disability, confusion, or psychiatric disorders
  • Prisoners
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cases

    Participants with lipedema

  • Controls

    Participants without lipedema

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What researchers measure

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

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37203, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2024 to primary completion in Jan 2026, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2023
First posted
Dec 26, 2023
StartActual
Feb 23, 2024
Primary completionActual
Jan 16, 2026
CompletionActual
Jan 16, 2026
Last update
Jun 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06180850
Responsible party
Aaron W. Aday, MD, MSc (Assistant Professor of Medicine, Vanderbilt University Medical Center) — Principal investigator
First posted
Dec 26, 2023
Start date
Feb 23, 2024
Primary completion
Jan 16, 2026
Completion
Jan 16, 2026
Last update
Jun 2, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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