Investigation of Systemic Inflammation Markers in Lipedema

NCT07787234 | Completed

• 1 other identifier: 2026-93
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipedema; Inflamation; Inflammation Biomarkers; Obesity & Overweight

Keywords

Lipedema, Inflammation , Index, Obesity

Outcome Measures

Primary Outcomes (1)

• Systemic Immuno-Inflammation Index (SII)

  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 Outcomes (4)

• Neutrophil to Lymphocyte Ratio (NLR)

  Baseline

• Platelet to Lymphocyte Ratio (PLR)

  Baseline

• Monocyte to Lymphocyte Ratio (MLR)

  Baseline

• CRP to Albumin Ratio (CAR)

  Baseline

Study Arms (3)

Group 1: Female patients with lipedema

Female patients with lipedema

Other: Clinical parameters; Other: Laboratory parameters

Group 2: Obese/overweight women

matched with female patients with lipedema based on age and BMI

Other: Laboratory parameters

Group 3: Healthy women with a BMI<25

matched with female patients with lipedema of the same age

Other: Laboratory parameters

Interventions

Clinical parameters OTHER

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.

Group 1: Female patients with lipedema

Laboratory parameters OTHER

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 1: Female patients with lipedema; Group 2: Obese/overweight women; Group 3: Healthy women with a BMI<25

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of lipedema
• Female patients aged 18-65 years
• Literacy
• Signing the informed consent form to participate in the study
• Female patients aged 18-65 years
• Age and BMI matched with patients with lipedema
• Literacy
• Signing the informed consent form to participate in the study
• Being female, aged 18-65
• BMI \<25
• Being literate
• Having signed the informed consent form by agreeing to participate in the study

You may not qualify if:

• Being under 18 or over 65 years of age
• Acute infection, autoimmune/rheumatological disease, malignancy, hematological disease, receiving steroid/immunosuppressive treatment
• Pregnancy
• Peripheral artery disease
• Severe cardiopulmonary failure (stage 3-4)
• Systemic diseases such as uncontrolled hypertension and diabetes
• Presence of cognitive impairment, hearing loss, communication difficulties that would hinder understanding of questionnaires and protocols

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Location

Related Publications (5)

• Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081.

  PMID: 36551837 BACKGROUND

• Kruppa P, Gohlke S, Lapinski K, Garcia-Carrizo F, Soultoukis GA, Infanger M, Schulz TJ, Ghods M. Lipedema stage affects adipocyte hypertrophy, subcutaneous adipose tissue inflammation and interstitial fibrosis. Front Immunol. 2023 Jul 28;14:1223264. doi: 10.3389/fimmu.2023.1223264. eCollection 2023.

  PMID: 37575263 BACKGROUND

• Duhon BH, Phan TT, Taylor SL, Crescenzi RL, Rutkowski JM. Current Mechanistic Understandings of Lymphedema and Lipedema: Tales of Fluid, Fat, and Fibrosis. Int J Mol Sci. 2022 Jun 14;23(12):6621. doi: 10.3390/ijms23126621.

  PMID: 35743063 BACKGROUND

• Amato AC. The Evolutionary Theory of Lipedema: A Perspective on Energy Storage and Chronic Inflammation. Cureus. 2025 Jul 26;17(7):e88809. doi: 10.7759/cureus.88809. eCollection 2025 Jul.

  PMID: 40861617 BACKGROUND

• Tel Adiguzel K, Yaman A, Kurklu NS, Adiguzel E. Dietary Inflammatory Index and Mediterranean Diet Score are associated with systemic inflammation in women with lipedema. Int J Obes (Lond). 2026 Feb;50(2):442-449. doi: 10.1038/s41366-025-01960-w. Epub 2025 Nov 27.

  PMID: 41310256 BACKGROUND

MeSH Terms

Conditions

Lipedema; Obesity; Overweight; Inflammation; Erythema Multiforme

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Erythema; Skin Diseases; Skin Diseases, Vesiculobullous

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Ph.D.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: August 26, 2026
• Study Start: June 1, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 20, 2026
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)