Serum Maresin-1 Levels in Patients With Lipedema: A Cross-Sectional Study (LIP-MARES)
Evaluation of the Relationship Between Serum Maresin-1 Levels and Clinical and Inflammatory Parameters in Patients With Lipedema
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Lipedema is a chronic, progressive adipose tissue disorder that predominantly affects women and is characterized by symmetrical enlargement of the extremities, pain, tenderness, and easy bruising. Despite its increasing recognition, the underlying pathophysiological mechanisms remain incompletely understood. Current evidence suggests that adipose tissue dysfunction, microvascular alterations, and chronic low-grade inflammation may contribute to disease development and progression. Distinguishing lipedema from obesity and lymphedema remains a major clinical challenge, highlighting the need for reliable biological markers.
Maresin-1 is a macrophage-derived specialized pro-resolving lipid mediator involved in the active resolution of inflammation and the restoration of tissue homeostasis. Experimental and clinical studies have demonstrated its anti-inflammatory and immunomodulatory properties in several chronic inflammatory conditions. However, the relationship between circulating Maresin-1 levels and the clinical manifestations of lipedema has not been adequately investigated.
This study is designed as a single-center, cross-sectional, observational study including three groups: women with clinically diagnosed lipedema, obese women without lipedema, and healthy female controls. A total of 84 participants are planned to be enrolled, with 28 individuals in each group.
Serum Maresin-1 concentrations will be measured using the enzyme-linked immunosorbent assay (ELISA) method. Clinical assessments will include pain severity evaluated by the Visual Analog Scale (VAS), central sensitization assessed by the Central Sensitization Inventory (CSI), and health-related quality of life measured using the EuroQol-5D (EQ-5D). Routine inflammatory parameters, including C-reactive protein (CRP) and the neutrophil-to-lymphocyte ratio (NLR), will also be evaluated.
The primary objective of the study is to compare serum Maresin-1 levels among the three groups. Secondary objectives are to investigate the associations between Maresin-1 levels and pain severity, inflammatory parameters, central sensitization, and quality of life, as well as to explore the potential role of Maresin-1 as a biomarker for lipedema pathophysiology.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Zeynep Karakuzu Güngör, M.D
- Numero di telefono: +90 212 404 15 00
- Email: zeynepkarakuzu@hotmail.com.tr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Female participants aged 18 to 65 years. Women with a clinical diagnosis of lipedema for the lipedema group. Women with obesity (body mass index ≥30 kg/m²) and without a diagnosis of lipedema for the obesity group.
Healthy female volunteers without chronic or inflammatory diseases for the healthy control group.
No acute infection within the previous 3 months. Ability and willingness to provide written informed consent.
Exclusion Criteria:
- Active infection at the time of enrollment. History of autoimmune or chronic inflammatory disease. History of malignancy. Pregnancy or breastfeeding. Current use of corticosteroids or immunosuppressive medications. Regular use of anti-inflammatory medications that may affect inflammatory biomarkers.
Acute infection within the previous 3 months. Inability to comply with study procedures or complete study assessments. Refusal or inability to provide written informed consent.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Lipedema
Women with clinically diagnosed lipedema.
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Obesity
Women with obesity (BMI ≥30 kg/m²) without clinical lipedema.
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Healthy Control
Healthy women without lipedema or obesity and without chronic inflammatory disease.
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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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Serum Maresin-1 Level
Lasso di tempo: At baseline (single assessment during study participation)
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The primary outcome is the serum Maresin-1 concentration measured in peripheral venous blood samples using a commercially available enzyme-linked immunosorbent assay (ELISA).
Serum Maresin-1 levels will be compared among women with lipedema, obese women without lipedema, and healthy controls.
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At baseline (single assessment during study participation)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Severity (Visual Analog Scale, VAS)
Lasso di tempo: At baseline (single assessment during study participation)
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Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS).
Higher scores indicate greater pain severity.
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At baseline (single assessment during study participation)
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Central Sensitization Inventory (CSI) Score
Lasso di tempo: At baseline (single assessment during study participation)
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Central sensitization symptoms will be evaluated using the Central Sensitization Inventory (CSI).
Higher scores indicate greater central sensitization.
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At baseline (single assessment during study participation)
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LIP-MAR-2026-001
Informazioni su farmaci e dispositivi, documenti di studio
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