Evaluation of the Relationship Between Serum Maresin-1 Levels and Clinical and Inflammatory Parameters in Patients With Lipedema
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 主要终点
- Serum Maresin-1 Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Obesity
Women with obesity (BMI ≥30 kg/m²) without clinical lipedema.
Healthy Control
Healthy women without lipedema or obesity and without chronic inflammatory disease.
Lipedema
Women with clinically diagnosed lipedema.
结局指标
主要结局
Serum Maresin-1 Level
时间窗: 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.
次要结局
- Pain Severity (Visual Analog Scale, VAS)(At baseline (single assessment during study participation))
- Central Sensitization Inventory (CSI) Score(At baseline (single assessment during study participation))
研究者
Zeynep Karakuzu Güngör
Physical Medicine and Rehabilitation Specialist
Kanuni Sultan Suleyman Training and Research Hospital