Investigation of Systemic Inflammation Markers in Lipedema

August 24, 2026 updated by: Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Systemic Inflammatory Indices in Lipedema Compared With BMI-Matched Obesity: The Distinct Clinical Relevance of the C-Reactive Protein-to-Albumin Ratio

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Uskudar
      • Istanbul, Uskudar, Turkey (Türkiye)
        • Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population consists of adult female patients who presented to our hospital's Physical Medicine and Rehabilitation outpatient clinic and were clinically diagnosed with lipedema. The control group will consist of healthy female individuals evaluated at the same center who do not have a diagnosis of lipedema or lymphedema and have similar age characteristics. Sample size analysis will be performed using the G*Power 3.1 program. Since the primary endpoint of the study is defined as the difference in SII between the lipedema and control groups, the comparison of the means of three independent groups will be the basis. In a two-tailed analysis, with Cohen's d = 0.60 effect size, alpha error level 0.05, and power 80%, 64 participants per group, totaling 192 participants, are required.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Female patients with lipedema
Female patients with lipedema
Other: Clinical 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.
Other: Laboratory 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. 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.
Group 2: Obese/overweight women
matched with female patients with lipedema based on age and BMI
Other: Laboratory 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. 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.
Group 3: Healthy women with a BMI<25
matched with female patients with lipedema of the same age
Other: Laboratory 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic Immuno-Inflammation Index (SII)
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutrophil to Lymphocyte Ratio (NLR)
Time Frame: 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.
Baseline
Platelet to Lymphocyte Ratio (PLR)
Time Frame: 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.
Baseline
Monocyte to Lymphocyte Ratio (MLR)
Time Frame: Baseline
MLR: Calculated as Monocyte/Lymphocyte. High MLR is associated with increased inflammation and impaired immune response.
Baseline
CRP to Albumin Ratio (CAR)
Time Frame: Baseline
CAR: Calculated as CRP/Albumin. It is an index reflecting both inflammation and nutritional/protein reserves.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Actual)

August 1, 2026

Study Completion (Actual)

August 20, 2026

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

August 24, 2026

First Posted (Actual)

August 26, 2026

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-93

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data generated and analyzed during this study will not be publicly shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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