Building Lipedema Research Resources (BRR)

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 Overview

• Status: Recruiting
• Conditions: Lipedema

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Caroline Crush, MSHA; Phone Number: 615-421-0243; Email: caroline.crush@vumc.org
• Study Contact Backup: Name: Aaron Aday, MD; Email: aaron.w.aday@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: Study Coordinator; Phone Number: 615-421-0243; Email: caroline.crush@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with or without lipedema

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cases; Participants with lipedema
Controls; Participants without lipedema

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
We will measure plasma concentrations of CD8A.	1 day
We will measure plasma concentrations of high-sensitivity C-reactive protein.	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Lipedema
• Other Study ID Numbers: 212427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No