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NCT05394467Completed

Adipose Cellular Kinetics of Lipedema

A Novel Approach to Examine the Adipose Cellular Kinetics of Lipedema

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

Lipedema is characterized by an abnormal deposition of adipose tissue, resulting in fluid accumulation, limb enlargement, and pain. Lipedema is often misdiagnosed as simply obesity. A major challenge with diagnosis is the poorly understood biology underlying the disease. Limited studies suggest that the development of lipedema may involve adipocyte hypertrophy, increased commitment of adipose progenitor cells, hypoxia, adipocyte necrosis and macrophage recruitment. There remains an urgent need to investigate novel characteristics of adipose remodeling that may contribute to the pathogenesis of lipedema. The study investigators have reported quantitative measures of in vivo adipose kinetics using an 8-week incorporation of deuterium (administered as 2H2O) into the adipose tissue of women with obesity. The objective of this proposal is to utilize the metabolic 2H-labeling approach to measure, for the first time, in vivo adipocyte formation and triglyceride synthesis in the adipose tissue of participants with lipedema. Imaging approaches will provide a range of measurements to characterize the lipedema depots. The investigators hypothesize that lipedema adipose depots will have higher rates of adipocyte formation and triglyceride synthesis than both non-lipedema depots and those of women with traditional obesity. Lipedema may involve adipose tissue remodeling, characterized by adipocyte hypertrophy and increased commitment of preadipocytes and differentiation of adipocytes (adipogenesis), yielding an abundance of adipocytes with limited capacity to expand and accommodate lipid, resulting in hypoxia, macrophage recruitment, and local/systemic inflammation. Findings from this proposal will contribute to a better understanding of the pathogenesis of lipedema and may provide insight for the future development of therapeutic targets.

Status (registry)
Completed
Study type
Observational
Enrollment
17 (actual)
First submitted
23 May 2022
Start date
7 Apr 2022
Primary completion date
25 Nov 2025
Lead sponsor
Pennington Biomedical Research Center
Diseases
Obesity
NCT number
NCT05394467

What you commit to

  • Study type: Observational
  • Participants enrolled: 17
  • From 7 Apr 2022 to the primary completion date, 25 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chronic use of systemic glucocorticoids, atypical anti-psychotic medications, or medications that cause clinically significant changes in weight

Other illness

  • Have major organ disease (heart, kidney, lung, thyroid, liver) or abnormal liver enzymes that represent a problem for study inclusion
  • Self-reported positive test for HIV, hepatitis B and hepatitis C
  • Any medical, psychiatric or behavioral factors that may interfere with study participation

Other

  • Pregnancy or breastfeeding in the next 3 months
  • Partial and/or full hysterectomy (due to estrogen effects on adipogenesis)
  • PCOS
  • Smoking or use of tobacco products in the last 6 months

Who the study is looking for

  • BMI ≤50 kg/m2
  • Waist/hip ratio \<0.86 (standing position)
  • Clinical diagnosis of lipedema (mostly Stage 3 but Stage 2 will not be excluded)
  • Willing to drink deuterated water (2H2O)

Age in the registry: 18 years to 45 years · Sex: Female

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pennington Biomedical Research Center
Coordinator of this site? Confirm its status
Baton RougeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.