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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06180850
Other study ID # 212427
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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