Lipedema, Inflamation, Inflammation Biomarkers, Obesity & Overweight
Conditions
Keywords
Lipedema, Inflammation , Index, Obesity
Brief summary
The aim of this study is to evaluate systemic inflammation in individuals with lipedema using hematological and biochemical inflammation indices and to examine the relationship between these indices and clinical findings. Additionally, the study aims to evaluate whether systemic inflammatory markers serve as objective biomarkers reflecting lipedema progression and clinical severity, and to assess their practical applicability in clinical practice. Hypothesis: Systemic inflammation markers are higher in the lipedema group compared to healthy controls, and these markers are associated with clinical severity.
Detailed description
Although the current literature demonstrates local inflammation secondary to microvascular dysregulation and macrophage infiltration at the subcutaneous adipose tissue level, the impact of this pathological cascade on systemic circulation has not been sufficiently investigated. This research aims to comprehensively elucidate the systemic inflammatory component of lipedema for the first time in the literature by analyzing the pro-inflammatory and immunoregulatory status in lipedema cases through objective, quantitative, and standardized hematological biomarkers such as systemic hematological and biochemical indices. Furthermore, it is believed that examining the correlation of this inflammatory load with clinical findings will contribute to understanding the progression mechanisms of lipedema. The aim of this research is to determine whether indices derived from complete blood count and biochemical hematological data, which are routine and low-cost tests, are valid inflammatory biomarkers in the pathology of lipedema. The main expected benefit is to provide clinicians with new, non-invasive, rapid, and cost-effective parameters that can be used in the differential diagnosis, clinical staging, and determination of progression risk of lipedema. It is also thought that demonstrating the inflammatory basis of the disease at the systemic level will lay the groundwork for identifying future therapeutic targets (anti-inflammatory or immunomodulatory agents).
Interventions
OTHERClinical parameters
Demographic and clinical data will be recorded. From the existing laboratory parameters in the system for all participants, the parameters suitable for the study, as described below, will be recorded. Blood tests will not be requested from participants. Only lipedema patients will be asked to complete the scales; in addition to clinical parameters, an ultrasound evaluation will be performed on lipedema patients. No invasive procedures or treatments will be administered to the patients. For all participants, the following laboratory parameters will be recorded: in the complete blood count, neutrophils, lymphocytes, monocytes, platelets, red blood cell distribution width , and mean platelet volume ; and in the biochemical analysis, C-reactive protein , erythrocyte sedimentation rate, and albumin levels.
Demographic and clinical data will be recorded. From the existing laboratory parameters in the system for all participants, the parameters suitable for the study, as described below, will be recorded. Blood tests will not be requested from participants. For all participants, the following laboratory parameters will be recorded: in the complete CBC, neutrophils, lymphocytes, monocytes, platelets, red blood cell distribution width , and mean platelet volume ; and in the biochemical analysis, C-reactive protein, erythrocyte sedimentation rate, and albumin levels.
Sponsors
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1\. Inclusion Criteria (Patient Group) 1. Diagnosis of lipedema 2. Female patients aged 18-65 years 3. Literacy 4. Signing the informed consent form to participate in the study 2\. Inclusion Criteria (Obese-Overweight Control Group) 1. Female patients aged 18-65 years 2. Age and BMI matched with patients with lipedema 3. Literacy 4. Signing the informed consent form to participate in the study 3\. Inclusion criteria (healthy control group) 1. Being female, aged 18-65 2. BMI \<25 3. Being literate 4. Having signed the informed consent form by agreeing to participate in the study
Exclusion criteria
1. Being under 18 or over 65 years of age 2. Acute infection, autoimmune/rheumatological disease, malignancy, hematological disease, receiving steroid/immunosuppressive treatment 3. Pregnancy 4. Peripheral artery disease 5. Severe cardiopulmonary failure (stage 3-4) 6. Systemic diseases such as uncontrolled hypertension and diabetes 7. Presence of cognitive impairment, hearing loss, communication difficulties that would hinder understanding of questionnaires and protocols
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Immuno-Inflammation Index (SII) | Baseline | SII will be calculated as = Platelet × Neutrophil / Lymphocyte The SII index is calculated using hemogram parameters and indicates the balance between pro-inflammatory response and immunological regulation. A high SII value indicates increased pro-inflammatory activity in the systemic circulation and/or suppressed lymphocytic immune response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neutrophil to Lymphocyte Ratio (NLR) | Baseline | NLR: Calculated as Neutrophil/Lymphocyte . A value of \~1-2 is considered physiological, 2-3 is a gray area or subclinical low-grade inflammation, and \>3 is considered pathological or systemic inflammation. It is used to predict disease severity and mortality risk in many diseases such as sepsis, pneumonia, cancer, and cardiovascular diseases. There is no single, definitive cutoff value for all diseases; threshold values may vary depending on the situation. |
| Platelet to Lymphocyte Ratio (PLR) | Baseline | PLR: Calculated as Platelet/Lymphocyte. It summarizes the combination of high platelets (pro-inflammatory/pro-thrombotic) and low lymphocytes (weakened immune response) in a single value. |
| Monocyte to Lymphocyte Ratio (MLR) | Baseline | MLR: Calculated as Monocyte/Lymphocyte. High MLR is associated with increased inflammation and impaired immune response. |
| CRP to Albumin Ratio (CAR) | Baseline | CAR: Calculated as CRP/Albumin. It is an index reflecting both inflammation and nutritional/protein reserves. |
Countries
Turkey (Türkiye)
Outcome results
None listed