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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lipedema

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Zeynep Karakuzu Güngör, M.D; Phone Number: +90 212 404 15 00; Email: zeynepkarakuzu@hotmail.com.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult women aged 18 to 65 years recruited from the Physical Medicine and Rehabilitation outpatient clinic of a tertiary care hospital. Participants will be classified into three groups: (1) women with clinically diagnosed lipedema, (2) women with obesity (body mass index ≥30 kg/m²) without lipedema, and (3) healthy female volunteers without chronic or inflammatory diseases. A total of 84 participants are planned to be enrolled, with 28 individuals in each group. The study aims to compare serum Maresin-1 levels and their associations with clinical and inflammatory parameters across these populations.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Maresin-1 Level	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity (Visual Analog Scale, VAS)	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	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)

Collaborators and Investigators

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lipedema
• Other Study ID Numbers: LIP-MAR-2026-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No