Status:
COMPLETED
Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Lipedema Foundation
Conditions:
Lipedema
Metabolism
Eligibility:
FEMALE
18-68 years
Phase:
NA
Brief Summary
Lipedema is a disorder characterized by massive, bilateral accumulation of fat below the waist and in the legs. Enlargement of the lower extremities is often accompanied by leg pain and accumulation o...
Detailed Description
Once informed consent has been obtained, participants will complete a screening visit that will include a medical history, physical examination, pregnancy test (for women of childbearing potential), b...
Eligibility Criteria
Inclusion
- Diagnosis of Lipedema
- Lean women with lipedema (BMI \>19.5 kg/m² and \<26.0 kg/m²)
- Women with obesity and lipedema (BMI \>30.0 kg/m² and \<50.0 kg/m²)
Exclusion
- Medical, surgical or biological menopause
- Previous bariatric surgery
- Diagnosis of Type 2 Diabetes
- HbA1C \<5.7%
- Structured exercise \>2 days/week for ≥35 minutes of intense exercise (e.g., jogging, activity that cause heavy breathing and sweating) or ≥150 minutes per week of structured exercise (e.g., brisk walking)
- Unstable weight (\>4% change in weight during the last 2 months before entering the study)
- Significant organ system dysfunction (e.g., diabetes, severe pulmonary, kidney or cardiovascular disease)
- Cancer or cancer that has been in remission for \<5 years
- Polycystic Ovary Syndrome
- Major psychiatric illness
- Conditions that render participant unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)
- Use of medications that are known to affect the study outcome measures (e.g., steroids, non-statin lipid-lowering medications) or increase the risk of study procedures (e.g., anticoagulants) and that cannot be temporarily discontinued for this study
- Smoke cigarettes \>10 cigarettes/week
- Consume \>14 units of alcohol per week
- Pregnant or lactating women
- Persons who are not able to grant voluntary informed consent
- Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2025
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03271034
Start Date
August 1 2017
End Date
March 24 2025
Last Update
March 28 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110