Lipedema, Obesity, Body Mass Index, Bioelectrical Impedance Analysis
Conditions
Keywords
Lipedema, Obesity, Index
Brief 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.
Detailed description
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.
Interventions
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.
OTHERNumeric Rating Scale
Pain intensity will be evaluated using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain).
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.
OTHERShort Form-12
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.
OTHERClinical Staging
Lipedema stage will be determined according to clinical examination findings and established diagnostic criteria.
Sponsors
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of the total fat mass of the two legs to total body fat mass | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total fat mass | Baseline | Total fat mass will be measured in kilograms using bioelectrical impedance analysis and represents the estimated total amount of fat mass in the body. |
| Fat-free body mass | Baseline | Fat-free body mass will be measured in kilograms using bioelectrical impedance analysis and represents total body mass excluding fat mass. |
| Total and skeletal muscle mass | Baseline | 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. |
| Total body water | Baseline | Total body water will be measured in kilograms using bioelectrical impedance analysis and represents the estimated total amount of water in the body. |
| Visceral fat level | Baseline | 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. |
| Leg-to-trunk fat ratio | Baseline | 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. |
| Leg-to-arm fat ratio | Baseline | 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. |
| Leg muscle-to-fat ratio | Baseline | 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. |
| Right-left extremity asymmetry | Baseline | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFeyza Nur Yücel, Assoc. Prof.
PRINCIPAL_INVESTIGATORFeyza Nur Yücel, Assoc. Prof.
Saglik Bilimleri Universitesi
Outcome results
None listed