Serum Maresin-1 Levels in Patients With Lipedema: A Cross-Sectional Study
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Lipedema. Базовые параметры: 18 лет — 65 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of the Relationship Between Serum Maresin-1 Levels and Clinical and Inflammatory Parameters in Patients With Lipedema
Обзор
Lipedema is a chronic and progressive adipose tissue disorder characterized by symmetrical fat accumulation, pain, tenderness, and easy bruising, predominantly affecting women. Increasing evidence suggests that chronic low-grade inflammation and impaired resolution of inflammation may contribute to its pathophysiology. Maresin-1 is a specialized pro-resolving lipid mediator with potent anti-inflammatory and tissue-protective properties; however, its role in lipedema remains largely unknown. This cross-sectional observational study aims to evaluate serum Maresin-1 levels in women with lipedema and to investigate their associations with pain severity, inflammatory markers, central sensitization, and quality of life. Serum Maresin-1 levels and clinical characteristics will be compared among women with lipedema, obese women without lipedema, and healthy controls to explore the potential value of Maresin-1 as a biomarker in lipedema.
Подробное описание
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.
Первичные конечные точки
- Serum Maresin-1 Level [Срок оценки: At baseline (single assessment during study participation)]
Вторичные конечные точки (2)
- Pain Severity (Visual Analog Scale, VAS) [Срок оценки: At baseline (single assessment during study participation)]
- Central Sensitization Inventory (CSI) Score [Срок оценки: At baseline (single assessment during study participation)]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07651813 · LIP-MAR-2026-001