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Investigation of Systemic Inflammation Markers in Lipedema

24 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Observationnel

Inscription (Réel)

192

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Oui

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Group 1: Female patients with lipedema
Female patients with lipedema
Autre: 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.
Autre: 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
Autre: 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
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Systemic Immuno-Inflammation Index (SII)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Neutrophil to Lymphocyte Ratio (NLR)
Délai: 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)
Délai: 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)
Délai: Baseline
MLR: Calculated as Monocyte/Lymphocyte. High MLR is associated with increased inflammation and impaired immune response.
Baseline
CRP to Albumin Ratio (CAR)
Délai: Baseline
CAR: Calculated as CRP/Albumin. It is an index reflecting both inflammation and nutritional/protein reserves.
Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 juin 2026

Achèvement primaire (Réel)

1 août 2026

Achèvement de l'étude (Réel)

20 août 2026

Dates d'inscription aux études

Première soumission

6 juillet 2026

Première soumission répondant aux critères de contrôle qualité

24 août 2026

Première publication (Réel)

26 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

26 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026-93

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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