LipedemaLIPEDEMANCT05394467
Adipose Cellular Kinetics of Lipedema
An observational study of Lipedema, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Lipedema
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2022to 25 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Adult
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
Who may be able to join
- 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)
Who cannot join
- Have major organ disease (heart, kidney, lung, thyroid, liver) or abnormal liver enzymes that represent a problem for study inclusion
- Chronic use of systemic glucocorticoids, atypical anti-psychotic medications, or medications that cause clinically significant 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 HIV, hepatitis B and hepatitis C
- Smoking or use of tobacco products in the last 6 months
- Any medical, psychiatric or behavioral factors that may interfere with study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: A Novel Approach to Examine the Adipose Cellular Kinetics of Lipedema
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.
- Conditions
- Lipedema
- Keywords
- Adipose tissue, Lipedema, Subcutaneous abdominal, Subcutaneous femoral, Adipocyte, Adipose turnover, Adipose kinetics, Adipogenesis, Deuterium, Obesity
- Medical subject headings
- Lipedema, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lipedema | Women with diagnosed lipedema |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start7 Apr 2022
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lipedema Foundation
- Responsible party
- Principal investigator, Ursula White, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05394467
- Sponsor's protocol ID
- PBRC 2021-051
- Acronym
- LIPEDEMA
- Status last verified
- Apr 2026
- First submitted
- 23 May 2022
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Examine the Adipose Cellular Kinetics of Lipedema
- ClinicalTrials.gov ID
- NCT05394467
- Acronym / sponsor ID
- LIPEDEMA / PBRC 2021-051
- Conditions
- Lipedema
- Keywords
- Adipose tissue, Lipedema, Subcutaneous abdominal, Subcutaneous femoral, Adipocyte, Adipose turnover, Adipose kinetics, Adipogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Lipedema Foundation
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipedema | – | –Women with diagnosed lipedema |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- Have major organ disease (heart, kidney, lung, thyroid, liver) or abnormal liver enzymes that represent a problem for study inclusion
- Chronic use of systemic glucocorticoids, atypical anti-psychotic medications, or medications that cause clinically significant changes in weight
- Pregnancy or breastfeeding in the next 3 months
- Partial and/or full hysterectomy (due to estrogen effects on adipogenesis)
- PCOS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess in vivo adipocyte formation in lipedema adipose depots (femoral) and non-lipedema depots (abdominal,) from patients with lipedema.
Time frame: 8 weeks
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.
1 secondary outcome
Assess in vivo triglyceride formation in lipedema adipose depots (femoral) and non-lipedema depots (abdominal,) from patients with lipedema.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess in vivo adipocyte formation in lipedema adipose depots (femoral) and non-lipedema depots (abdominal,) from patients with lipedema. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.