An observational study in Lipedema, Obesity and Body Mass Index, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Observational
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.
This cross-sectional observational study aims to evaluate body composition characteristics in women with lipedema and examine their associations with clinical symptoms and functional status. Body composition will be assessed using bioelectrical impedance analysis, including body fat percentage, muscle mass, total body water, visceral fat level, and segmental body composition parameters. Anthropometric measurements and lipedema-related clinical characteristics will also be recorded. Pain severity, lower-extremity function, and health-related quality of life will be evaluated using validated patient-reported outcome measures. The findings obtained from this study are not intended to establish the diagnosis of lipedema based solely on BIA measurement; rather, they are expected to contribute to the identification of objective and measurable body composition indicators that can support existing clinical assessment. The segmental parameters and candidate distribution indices to be identified may offer research indicators that could be validated in different samples in the future. Furthermore, demonstrating the relationship between regional fat and muscle distribution and pain and lower extremity function in women with lipedema may contribute to the development of a more comprehensive approach that can be used in the evaluation and follow-up of patients.
83 studies on the registry are indexed under Lipedema; 31 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 42 observational studies indexed under Lipedema.
Browse Lipedema studies →Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 107 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adult female patients diagnosed with lipedema who present to the Physical Medicine and Rehabilitation Outpatient Clinic during the study period, along with female volunteers with a similar mean BMI who are evaluated at the outpatient clinic.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Inclusion Criteria (Lipedema Group)
2. Inclusion Criteria (BMI-Matched Obese Group)
Exclusion Criteria:
Group/Cohort Description: Female patients with lipedema
Other: Bioelectrical Impedance Analysis · Other: Numeric Rating Scale · Other: Lower Extremity Functional Scale · Other: Short Form-12 · Other: Clinical Staging
BMI-matched obese women
Other: Bioelectrical Impedance Analysis
Body composition will be assessed using bioelectrical impedance analysis. Total and segmental body composition parameters, including body fat mass, body fat percentage, muscle mass, and total body water, will be recorded.
Pain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).
Also known as: NRS
Functional status will be assessed using the Lower Extremity Functional Scale. The total score ranges from 0 to 80, with higher scores indicating better lower extremity function and lower disability levels.
Also known as: LEFS
Health-related quality of life will be assessed using the SF-12 questionnaire, including the Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores. Scores range from 0 to 100, with higher scores indicating better perceived health status and quality of life.
Also known as: SF-12
Lipedema stage will be determined according to clinical examination findings and established diagnostic criteria.
Ratio of the total fat mass of the two legs to total body fat mass
The ratio will be calculated by dividing the sum of the fat mass of both legs by total body fat mass, as measured using bioelectrical impedance analysis.
Time frame: Baseline
Total fat mass
Total fat mass will be measured in kilograms using bioelectrical impedance analysis and represents the estimated total amount of fat mass in the body.
Time frame: Baseline
Fat-free body mass
Fat-free body mass will be measured in kilograms using bioelectrical impedance analysis and represents total body mass excluding fat mass.
Time frame: Baseline
Total and skeletal muscle mass
Total muscle mass and skeletal muscle mass will be measured in kilograms using bioelectrical impedance analysis and represent the estimated amounts of total muscle tissue and skeletal muscle tissue in the body, respectively.
Time frame: Baseline
Total body water
Total body water will be measured in kilograms using bioelectrical impedance analysis and represents the estimated total amount of water in the body.
Time frame: Baseline
Visceral fat level
Visceral fat level will be assessed using bioelectrical impedance analysis and reported as a device-generated rating reflecting the estimated amount of fat surrounding the internal abdominal organs.
Time frame: Baseline
Leg-to-trunk fat ratio
The leg-to-trunk fat ratio will be calculated by dividing the sum of the fat mass of both legs by trunk fat mass, as measured using bioelectrical impedance analysis.
Time frame: Baseline
Leg-to-arm fat ratio
The leg-to-arm fat ratio will be calculated by dividing the sum of the fat mass of both legs by the sum of the fat mass of both arms, as measured using bioelectrical impedance analysis.
Time frame: Baseline
Leg muscle-to-fat ratio
The leg muscle-to-fat ratio will be calculated by dividing the total muscle mass of both legs by the total fat mass of both legs, as measured using bioelectrical impedance analysis.
Time frame: Baseline
Right-left extremity asymmetry
Right-left extremity asymmetry will be assessed by calculating the absolute differences in fat mass and muscle mass between the right and left upper and lower extremities, as measured using bioelectrical impedance analysis.
Time frame: Baseline
Plan to share: No — The individual participant data generated and analyzed during this study will not be publicly shared.
Started Sep 2026 (actual). Primary completion is estimated for Nov 2026, 2 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey →