Investigation of Systemic Inflammation Markers in Lipedema
24 de agosto de 2026 actualizado por: Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Systemic Inflammatory Indices in Lipedema Compared With BMI-Matched Obesity: The Distinct Clinical Relevance of the C-Reactive Protein-to-Albumin Ratio
The aim of this study is to evaluate systemic inflammation in individuals with lipedema using hematological and biochemical inflammation indices and to examine the relationship between these indices and clinical findings. Additionally, the study aims to evaluate whether systemic inflammatory markers serve as objective biomarkers reflecting lipedema progression and clinical severity, and to assess their practical applicability in clinical practice.
Hypothesis: Systemic inflammation markers are higher in the lipedema group compared to healthy controls, and these markers are associated with clinical severity.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
Although the current literature demonstrates local inflammation secondary to microvascular dysregulation and macrophage infiltration at the subcutaneous adipose tissue level, the impact of this pathological cascade on systemic circulation has not been sufficiently investigated. This research aims to comprehensively elucidate the systemic inflammatory component of lipedema for the first time in the literature by analyzing the pro-inflammatory and immunoregulatory status in lipedema cases through objective, quantitative, and standardized hematological biomarkers such as systemic hematological and biochemical indices. Furthermore, it is believed that examining the correlation of this inflammatory load with clinical findings will contribute to understanding the progression mechanisms of lipedema.
The aim of this research is to determine whether indices derived from complete blood count and biochemical hematological data, which are routine and low-cost tests, are valid inflammatory biomarkers in the pathology of lipedema. The main expected benefit is to provide clinicians with new, non-invasive, rapid, and cost-effective parameters that can be used in the differential diagnosis, clinical staging, and determination of progression risk of lipedema. It is also thought that demonstrating the inflammatory basis of the disease at the systemic level will lay the groundwork for identifying future therapeutic targets (anti-inflammatory or immunomodulatory agents).
Tipo de estudio
De observación
Inscripción (Actual)
192
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Uskudar
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Istanbul, Uskudar, Turquía (Türkiye)
- Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
The study population consists of adult female patients who presented to our hospital's Physical Medicine and Rehabilitation outpatient clinic and were clinically diagnosed with lipedema.
The control group will consist of healthy female individuals evaluated at the same center who do not have a diagnosis of lipedema or lymphedema and have similar age characteristics.
Sample size analysis will be performed using the G*Power 3.1 program.
Since the primary endpoint of the study is defined as the difference in SII between the lipedema and control groups, the comparison of the means of three independent groups will be the basis.
In a two-tailed analysis, with Cohen's d = 0.60 effect size, alpha error level 0.05, and power 80%, 64 participants per group, totaling 192 participants, are required.
Descripción
Inclusion Criteria:
1. Inclusion Criteria (Patient Group)
- Diagnosis of lipedema
- Female patients aged 18-65 years
- Literacy
- Signing the informed consent form to participate in the study
2. Inclusion Criteria (Obese-Overweight Control Group)
- Female patients aged 18-65 years
- Age and BMI matched with patients with lipedema
- Literacy
- Signing the informed consent form to participate in the study
3. Inclusion criteria (healthy control group)
- Being female, aged 18-65
- BMI <25
- Being literate
- Having signed the informed consent form by agreeing to participate in the study
Exclusion Criteria:
- Being under 18 or over 65 years of age
- Acute infection, autoimmune/rheumatological disease, malignancy, hematological disease, receiving steroid/immunosuppressive treatment
- Pregnancy
- Peripheral artery disease
- Severe cardiopulmonary failure (stage 3-4)
- Systemic diseases such as uncontrolled hypertension and diabetes
- Presence of cognitive impairment, hearing loss, communication difficulties that would hinder understanding of questionnaires and protocols
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Group 1: Female patients with lipedema
Female patients with lipedema
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Demographic and clinical data will be recorded.
From the existing laboratory parameters in the system for all participants, the parameters suitable for the study, as described below, will be recorded.
Blood tests will not be requested from participants.
Only lipedema patients will be asked to complete the scales; in addition to clinical parameters, an ultrasound evaluation will be performed on lipedema patients.
No invasive procedures or treatments will be administered to the patients.
For all participants, the following laboratory parameters will be recorded: in the complete blood count, neutrophils, lymphocytes, monocytes, platelets, red blood cell distribution width , and mean platelet volume ; and in the biochemical analysis, C-reactive protein , erythrocyte sedimentation rate, and albumin levels.
Demographic and clinical data will be recorded.
From the existing laboratory parameters in the system for all participants, the parameters suitable for the study, as described below, will be recorded.
Blood tests will not be requested from participants.
For all participants, the following laboratory parameters will be recorded: in the complete CBC, neutrophils, lymphocytes, monocytes, platelets, red blood cell distribution width , and mean platelet volume ; and in the biochemical analysis, C-reactive protein, erythrocyte sedimentation rate, and albumin levels.
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Group 2: Obese/overweight women
matched with female patients with lipedema based on age and BMI
|
Demographic and clinical data will be recorded.
From the existing laboratory parameters in the system for all participants, the parameters suitable for the study, as described below, will be recorded.
Blood tests will not be requested from participants.
For all participants, the following laboratory parameters will be recorded: in the complete CBC, neutrophils, lymphocytes, monocytes, platelets, red blood cell distribution width , and mean platelet volume ; and in the biochemical analysis, C-reactive protein, erythrocyte sedimentation rate, and albumin levels.
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Group 3: Healthy women with a BMI<25
matched with female patients with lipedema of the same age
|
Demographic and clinical data will be recorded.
From the existing laboratory parameters in the system for all participants, the parameters suitable for the study, as described below, will be recorded.
Blood tests will not be requested from participants.
For all participants, the following laboratory parameters will be recorded: in the complete CBC, neutrophils, lymphocytes, monocytes, platelets, red blood cell distribution width , and mean platelet volume ; and in the biochemical analysis, C-reactive protein, erythrocyte sedimentation rate, and albumin levels.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Systemic Immuno-Inflammation Index (SII)
Periodo de tiempo: Baseline
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SII will be calculated as = Platelet × Neutrophil / Lymphocyte The SII index is calculated using hemogram parameters and indicates the balance between pro-inflammatory response and immunological regulation.
A high SII value indicates increased pro-inflammatory activity in the systemic circulation and/or suppressed lymphocytic immune response.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neutrophil to Lymphocyte Ratio (NLR)
Periodo de tiempo: Baseline
|
NLR: Calculated as Neutrophil/Lymphocyte .
A value of ~1-2 is considered physiological, 2-3 is a gray area or subclinical low-grade inflammation, and >3 is considered pathological or systemic inflammation.
It is used to predict disease severity and mortality risk in many diseases such as sepsis, pneumonia, cancer, and cardiovascular diseases.
There is no single, definitive cutoff value for all diseases; threshold values may vary depending on the situation.
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Baseline
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Platelet to Lymphocyte Ratio (PLR)
Periodo de tiempo: Baseline
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PLR: Calculated as Platelet/Lymphocyte.
It summarizes the combination of high platelets (pro-inflammatory/pro-thrombotic) and low lymphocytes (weakened immune response) in a single value.
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Baseline
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Monocyte to Lymphocyte Ratio (MLR)
Periodo de tiempo: Baseline
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MLR: Calculated as Monocyte/Lymphocyte. High MLR is associated with increased inflammation and impaired immune response.
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Baseline
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CRP to Albumin Ratio (CAR)
Periodo de tiempo: Baseline
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CAR: Calculated as CRP/Albumin.
It is an index reflecting both inflammation and nutritional/protein reserves.
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Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Kruppa P, Gohlke S, Lapinski K, Garcia-Carrizo F, Soultoukis GA, Infanger M, Schulz TJ, Ghods M. Lipedema stage affects adipocyte hypertrophy, subcutaneous adipose tissue inflammation and interstitial fibrosis. Front Immunol. 2023 Jul 28;14:1223264. doi: 10.3389/fimmu.2023.1223264. eCollection 2023.
- Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081.
- Duhon BH, Phan TT, Taylor SL, Crescenzi RL, Rutkowski JM. Current Mechanistic Understandings of Lymphedema and Lipedema: Tales of Fluid, Fat, and Fibrosis. Int J Mol Sci. 2022 Jun 14;23(12):6621. doi: 10.3390/ijms23126621.
- Amato AC. The Evolutionary Theory of Lipedema: A Perspective on Energy Storage and Chronic Inflammation. Cureus. 2025 Jul 26;17(7):e88809. doi: 10.7759/cureus.88809. eCollection 2025 Jul.
- Tel Adiguzel K, Yaman A, Kurklu NS, Adiguzel E. Dietary Inflammatory Index and Mediterranean Diet Score are associated with systemic inflammation in women with lipedema. Int J Obes (Lond). 2026 Feb;50(2):442-449. doi: 10.1038/s41366-025-01960-w. Epub 2025 Nov 27.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2026
Finalización primaria (Actual)
1 de agosto de 2026
Finalización del estudio (Actual)
20 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de agosto de 2026
Publicado por primera vez (Actual)
26 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Enfermedades del tejido conectivo
- Enfermedades de la piel
- Enfermedades De La Piel Vesiculoampollosa
- Eritema
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Enfermedades de la piel y del tejido conectivo
- Signos y síntomas
- Exceso de peso
- Obesidad
- Inflamación
- Lipedema
- Eritema multiforme
Otros números de identificación del estudio
- 2026-93
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The individual participant data generated and analyzed during this study will not be publicly shared.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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