- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05394467
Adipose Cellular Kinetics of Lipedema (LIPEDEMA)
June 6, 2023 updated by: Ursula White, Pennington Biomedical Research Center
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
24
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ursula White, PhD
- Phone Number: 2257632656
- Email: ursula.white@pbrc.edu
Study Contact Backup
- Name: Eric Ravussin, PhD
- Email: eric.ravussin@pbrc.edu
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Recruiting
- Pennington Biomedical Research Center
-
Contact:
- Ursula White, PhD
- Phone Number: 225-763-2656
- Email: ursula.white@pbrc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
N/A
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
Description
Inclusion Criteria:
- 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)
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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
Lipedema
Women with diagnosed lipedema
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess in vivo triglyceride 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 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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2022
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (Actual)
May 27, 2022
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
June 6, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2021-051
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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