Serum Maresin-1 Levels in Patients With Lipedema: A Cross-Sectional Study

ConditionLipedema
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

84 Participants
are grouped into 3 trial groups
Group A: Lipedema
Group B: Obesity
Group C: Healthy Control

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline (single assessment during study participation)

Secondary outcomes

1

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.

Time frame
At baseline (single assessment during study participation)
2

Central Sensitization Inventory (CSI) Score

Central sensitization symptoms will be evaluated using the Central Sensitization Inventory (CSI). Higher scores indicate greater central sensitization.

Time frame
At baseline (single assessment during study participation)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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