Investigation of Systemic Inflammation Markers in Lipedema
24 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Effettivo)
192
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Uskudar
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Istanbul, Uskudar, Turchia (Türkiye)
- Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Systemic Immuno-Inflammation Index (SII)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Neutrophil to Lymphocyte Ratio (NLR)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 giugno 2026
Completamento primario (Effettivo)
1 agosto 2026
Completamento dello studio (Effettivo)
20 agosto 2026
Date di iscrizione allo studio
Primo inviato
6 luglio 2026
Primo inviato che soddisfa i criteri di controllo qualità
24 agosto 2026
Primo Inserito (Effettivo)
26 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Disturbi della nutrizione
- Ipernutrizione
- Peso corporeo
- Malattie del tessuto connettivo
- Malattie della pelle
- Malattie della pelle, vescicolobollose
- Eritema
- Condizioni patologiche, segni e sintomi
- Malattie nutrizionali e metaboliche
- Malattie della pelle e del tessuto connettivo
- Segni e sintomi
- Sovrappeso
- Obesità
- Infiammazione
- Lipedema
- Eritema multiforme
Altri numeri di identificazione dello studio
- 2026-93
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
The individual participant data generated and analyzed during this study will not be publicly shared.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .