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NCT05394467 · ClinicalTrials.gov registry record

Adipose Cellular Kinetics of Lipedema

A clinical trial of Lipedema, sponsored by Pennington Biomedical Research Center.

Recruiting
Registry status
24
Enrollment target
1
Study location

NCT05394467: Recruiting study of Lipedema, sponsored by Pennington Biomedical Research Center.

NCT05394467 is a study of Lipedema that is actively recruiting participants, run by Pennington Biomedical Research Center. The registered enrollment target is 24 participants, below the 211-participant average among 4 other Lipedema trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05394467, a study of Lipedema, is actively recruiting participants, sponsored by Pennington Biomedical Research Center.

RECRUITING
Registry status
24 participants
Enrollment target
1
Study location

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.

Primary Outcome

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.

Conditions Studied

Study Locations (1)

Louisiana

  • Pennington Biomedical Research Center - Baton Rouge

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2022-04-07
Est. Completion 2025-12-31

What NCT05394467 shows while recruiting

NCT05394467 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 211-participant average among 4 other Lipedema trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Lipedema appearing as the primary indexed condition, and to 0 interventions.

NCT05394467 reports a single indexed study location in Louisiana.

Frequently Asked Questions

What is clinical trial NCT05394467 about?

NCT05394467 is a clinical study titled "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...

What is the current status of trial NCT05394467?

This trial is currently recruiting. The enrollment target is 24 participants. The study started on 2022-04-07. Estimated completion is 2025-12-31.

What conditions does trial NCT05394467 study?

This clinical trial studies the following conditions: Lipedema.

Who is sponsoring clinical trial NCT05394467?

This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05394467 being conducted?

This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05394467, the US trial registry maintained by the National Library of Medicine. NCT05394467 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.