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CompletedNCT05394467LIPEDEMAUpdated Apr 8, 2026

Adipose Cellular Kinetics of Lipedema

An observational study in Lipedema, sponsored by Pennington Biomedical Research Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Sponsored by Pennington Biomedical Research Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
17
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Lipedema

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Keywords

  • Adipose tissue
  • Lipedema
  • Subcutaneous abdominal
  • Subcutaneous femoral
  • Adipocyte
  • Adipose turnover
  • Adipose kinetics
  • Adipogenesis
  • Deuterium
  • Obesity
03

In context

Lipedema

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

This study's enrollment of 17 is below the median of 90 across 42 observational studies indexed under Lipedema.

Browse Lipedema studies →

Lead sponsor

Pennington Biomedical Research Center is the lead sponsor of 284 studies on the registry; 31 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Women with diagnosed lipedema will be recruited and enrolled at Pennington Biomedical Research Center. A racially/ethnically diverse population will be recruited based on the local demographics

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≤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)

Exclusion criteria

Exclusion Criteria:

  • Have major organ disease (heart, kidney, lung, thyroid, liver) or abnormal liver enzymes that represent a problem for study inclusion
  • Chronic use of systemic , atypical anti-psychotic medications, or medications that cause changes in weight
  • Pregnancy or breastfeeding in the next 3 months
  • Partial and/or full hysterectomy (due to estrogen effects on adipogenesis)
  • PCOS
  • Self-reported positive test for , and
  • Smoking or use of tobacco products in the last 6 months
  • Any medical, psychiatric or behavioral factors that may interfere with study participation
Terms in these criteria, in plain language(6)

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.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • Lipedema

    Women with diagnosed lipedema

06

What researchers measure

Primary outcomes

  1. Assess in vivo adipocyte formation in lipedema adipose depots (femoral) and non-lipedema depots (abdominal,) from patients with lipedema.

    Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is enriched into the DNA of newly formed adipocytes. Lipedema adipose depots (femoral) will be compared to non-lipedema depots (abdominal) in these women with lipedema.

    Time frame: 8 weeks

Secondary outcomes

  1. Assess in vivo triglyceride formation in lipedema adipose depots (femoral) and non-lipedema depots (abdominal,) from patients with lipedema.

    Following the consumption of deuterium-labeled water (2H2O; heavy water), adipose tissue biopsies from the subcutaneous abdominal and femoral depots will be collected. The 2H from the heavy water is enriched into the glycerol moiety of triglycerides, reflecting recent triglyceride formation. Lipedema adipose depots (femoral) will be compared to non-lipedema depots (abdominal) in these women with lipedema.

    Time frame: 8 weeks

07

Study locations

1 site
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Nov 2025, 43 months.

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

Registered
May 23, 2022
First posted
May 27, 2022
StartActual
Apr 7, 2022
Primary completionActual
Nov 25, 2025
CompletionActual
Nov 25, 2025
Last update
Apr 8, 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 Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05394467
Collaborators
Lipedema Foundation
Responsible party
Ursula White (Assistant Professor, Pennington Biomedical Research Center) — Principal investigator
First posted
May 27, 2022
Start date
Apr 7, 2022
Primary completion
Nov 25, 2025
Completion
Nov 25, 2025
Last update
Apr 8, 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 Apr 2026. You cannot join it, but the record below documents what was studied.

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