Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05394467
Other study ID # PBRC 2021-051
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 7, 2022
Est. completion date February 28, 2025

Study information

Verified date June 2024
Source Pennington Biomedical Research Center
Contact Ursula White, PhD
Phone 2257632656
Email ursula.white@pbrc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Pennington Biomedical Research Center Baton Rouge Louisiana

Sponsors (2)

Lead Sponsor Collaborator
Pennington Biomedical Research Center Lipedema Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8 weeks
Secondary 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. 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT04492046 - Complex Decongestive Applications in Patients With Lipedema
Completed NCT04643392 - Physiotherapy Applications in Upper Extremity Lipedema
Recruiting NCT05464927 - Visualizing Vascular Mechanisms of Lipedema
Completed NCT02907411 - Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS) N/A
Completed NCT06238791 - Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease
Completed NCT03710798 - Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema N/A
Completed NCT03758651 - Williams Syndrome Strength, Hormones, Activity & Adiposity, DNA Programming, Eating Study
Not yet recruiting NCT04166084 - Trunk Stabilization Exercises at Lipoedema Patients N/A
Recruiting NCT05628948 - Vascular Lab Resource (VLR) Biorepository
Not yet recruiting NCT05944796 - Diathermy Effectiveness in Reducing Subcutaneous Adipose Tissue Affected by Lipedema N/A
Completed NCT05616962 - Collected Data of Medical Food, Vasculera or Diosmiplex, in Clinic Patients 20 to 70 Years Old Diagnosed With Lipedema N/A
Active, not recruiting NCT04632810 - Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema N/A
Recruiting NCT05284266 - The National Lipedema Study N/A
Active, not recruiting NCT06338059 - Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema
Completed NCT03492840 - Treatment of Women With Lipedema Involving Substantial Fat Knee of Women and Men With Nodular Dercum's Disease Phase 2
Completed NCT04076891 - Treatment of Women With Lipedema Involving Substantial Fat Above the Knee or of Women and Men With Nodular Dercum's Disease Phase 2
Recruiting NCT02838277 - Insight Into Subcutaneous Adipose Tissue Disorders N/A
Completed NCT05966779 - Physical Therapy in Lipedema Surgery
Recruiting NCT05488977 - The Effects of Endurance Training on Lipedema N/A
Completed NCT04213989 - Intermittent Pneumatic Compression in Women With Lipo-lymphedema (Lipedema With Swelling) N/A