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
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Zeynep Karakuzu Güngör, M.D
- Numer telefonu: +90 212 404 15 00
- E-mail: zeynepkarakuzu@hotmail.com.tr
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
Lipedema
Women with clinically diagnosed lipedema.
|
|
Obesity
Women with obesity (BMI ≥30 kg/m²) without clinical lipedema.
|
|
Healthy Control
Healthy women without lipedema or obesity and without chronic inflammatory disease.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Serum Maresin-1 Level
Ramy czasowe: At baseline (single assessment during study participation)
|
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.
|
At baseline (single assessment during study participation)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pain Severity (Visual Analog Scale, VAS)
Ramy czasowe: At baseline (single assessment during study participation)
|
Pain intensity will be assessed using the 10-cm Visual Analog Scale (VAS).
Higher scores indicate greater pain severity.
|
At baseline (single assessment during study participation)
|
|
Central Sensitization Inventory (CSI) Score
Ramy czasowe: At baseline (single assessment during study participation)
|
Central sensitization symptoms will be evaluated using the Central Sensitization Inventory (CSI).
Higher scores indicate greater central sensitization.
|
At baseline (single assessment during study participation)
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- LIP-MAR-2026-001
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .