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Investigation of Systemic Inflammation Markers in Lipedema

24. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Pozorovací

Zápis (Aktuální)

192

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Group 1: Female patients with lipedema
Female patients with lipedema
Jiný: 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.
Jiný: 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
Jiný: 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
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Systemic Immuno-Inflammation Index (SII)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Neutrophil to Lymphocyte Ratio (NLR)
Časové okno: 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)
Časové okno: 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)
Časové okno: Baseline
MLR: Calculated as Monocyte/Lymphocyte. High MLR is associated with increased inflammation and impaired immune response.
Baseline
CRP to Albumin Ratio (CAR)
Časové okno: Baseline
CAR: Calculated as CRP/Albumin. It is an index reflecting both inflammation and nutritional/protein reserves.
Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. června 2026

Primární dokončení (Aktuální)

1. srpna 2026

Dokončení studie (Aktuální)

20. srpna 2026

Termíny zápisu do studia

První předloženo

6. července 2026

První předloženo, které splnilo kritéria kontroly kvality

24. srpna 2026

První zveřejněno (Aktuální)

26. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. srpna 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2026-93

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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