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NCT07878299
Comparison of Segmental Body Composition Characteristics in Lipedema and Obesity
Conditions: Lipedema, Obesity, Body Mass Index, Bioelectrical Impedance Analysis
Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Enrollment: 200
Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Location: Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Uskudar Istanbul Uskudar
Summary
The aim of this study is to compare the total and regional body composition characteristics of women with lipedema and women without lipedema who are matched for age and body mass index, as determined by the TANITA MC-580 segmental bioelectrical impedance analysis (BIA) device. In addition to total fat mass and fat percentage, fat mass, fat-free mass, and muscle mass measurements of the right and left legs, right and left arms, and trunk are planned to be evaluated. From these measurements, regional distribution indicators such as the proportion of lower extremity fat mass within total body fat, the leg-to-trunk fat ratio, the leg-to-arm fat ratio, and the leg muscle-to-fat ratio will be calculated. In addition, the study aims to examine the relationships between segmental body composition characteristics and disease type and stage, disease duration, pain severity, and lower extremity function in the lipedema group.
Hypothesis: The proportion of total body fat located in the lower extremities is significantly higher in women with lipedema compared to women without lipedema matched for age and body mass index.
Eligibility Criteria
Inclusion Criteria:
1\. Inclusion Criteria (Lipedema Group)
1. Being female.
2. Being between 18-65 years of age.
3. Having received a diagnosis of lipedema based on clinical evaluation.
4. Being willing to participate in the study and signing the written informed consent form.
2\. Inclusion Criteria (BMI-Matched Obese Group)
1. Being female.
2. Being between 18-65 years of age.
3. Not meeting the diagnostic criteria for lipedema on clinical evaluation.
4. Showing similar characteristics to the lipedema group in terms of age and BMI.
5. Being willing to participate in the study and signing the written informed consent form.
Exclusion Criteria:
1. Being pregnant or breastfeeding.
2. Having a diagnosis of primary or secondary lymphedema.
3. Having clinically advanced-stage chronic venous insufficiency, an active venous ulcer, or a history of acute deep vein thrombosis.
4. Having a history of surgery or serious trauma within the last 6 months.
5. Having an active infection, cellulitis, or open wound.
6. Presence of edema due to congestive heart failure, advanced renal failure, or decompensated liver disease.
7. Having a diagnosis of active malignancy.
8. Having a neurological, rheumatological, or serious musculoskeletal disease that could affect the assessment.
9. Being unable to comply with study procedures or not providing informed consent.
Source: ClinicalTrials.gov (NCT07878299). StuddyBuddy aggregates publicly available trial information.