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Investigation of Systemic Inflammation Markers in Lipedema

24 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

192

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Turquia (Türkiye)
    • Uskudar
      • Istanbul, Uskudar, Turquia (Türkiye)
        • Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

Inclusion Criteria:

1. Inclusion Criteria (Patient Group)

  1. Diagnosis of lipedema
  2. Female patients aged 18-65 years
  3. Literacy
  4. Signing the informed consent form to participate in the study

2. Inclusion Criteria (Obese-Overweight Control Group)

  1. Female patients aged 18-65 years
  2. Age and BMI matched with patients with lipedema
  3. Literacy
  4. Signing the informed consent form to participate in the study

3. Inclusion criteria (healthy control group)

  1. Being female, aged 18-65
  2. BMI <25
  3. Being literate
  4. Having signed the informed consent form by agreeing to participate in the study

Exclusion Criteria:

  1. Being under 18 or over 65 years of age
  2. Acute infection, autoimmune/rheumatological disease, malignancy, hematological disease, receiving steroid/immunosuppressive treatment
  3. Pregnancy
  4. Peripheral artery disease
  5. Severe cardiopulmonary failure (stage 3-4)
  6. Systemic diseases such as uncontrolled hypertension and diabetes
  7. Presence of cognitive impairment, hearing loss, communication difficulties that would hinder understanding of questionnaires and protocols

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Group 1: Female patients with lipedema
Female patients with lipedema
Outro: Clinical parameters
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.
Outro: Laboratory parameters
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.
Group 2: Obese/overweight women
matched with female patients with lipedema based on age and BMI
Outro: Laboratory parameters
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.
Group 3: Healthy women with a BMI<25
matched with female patients with lipedema of the same age
Outro: Laboratory parameters
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Systemic Immuno-Inflammation Index (SII)
Prazo: Baseline
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.
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Neutrophil to Lymphocyte Ratio (NLR)
Prazo: 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.
Baseline
Platelet to Lymphocyte Ratio (PLR)
Prazo: Baseline
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.
Baseline
Monocyte to Lymphocyte Ratio (MLR)
Prazo: Baseline
MLR: Calculated as Monocyte/Lymphocyte. High MLR is associated with increased inflammation and impaired immune response.
Baseline
CRP to Albumin Ratio (CAR)
Prazo: Baseline
CAR: Calculated as CRP/Albumin. It is an index reflecting both inflammation and nutritional/protein reserves.
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2026

Conclusão Primária (Real)

1 de agosto de 2026

Conclusão do estudo (Real)

20 de agosto de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de agosto de 2026

Primeira postagem (Real)

26 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2026-93

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

The individual participant data generated and analyzed during this study will not be publicly shared.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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