LipedemaNCT07787234
Investigation of Systemic Inflammation Markers in Lipedema
An observational study of Lipedema and Inflamation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lipedema, Inflamation, Inflammation Biomarkers
- What is being tested?
- Clinical parameters and Laboratory parameters
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 20 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 1. Inclusion Criteria (Patient Group)
- Diagnosis of lipedema
- Female patients aged 18-65 years
- Literacy
- Signing the informed consent form to participate in the study
- 2. Inclusion Criteria (Obese-Overweight Control Group)
Show all 15Show fewer
- 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
- 3. Inclusion criteria (healthy control group)
- Being female, aged 18-65
- BMI <25
- Being literate
- Having signed the informed consent form by agreeing to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Uskudar
About this study
Official title: 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.
Read the 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).
- Conditions
- Lipedema, Inflamation, Inflammation Biomarkers, Obesity & Overweight
- Being tested
- Clinical parameters, Laboratory parameters
- Keywords
- Lipedema, Inflammation , Index, Obesity
- Medical subject headings
- Lipedema, Obesity, Overweight, Inflammation, Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical parametersOther
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.
Laboratory parametersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Female patients with lipedema | Female patients with lipedema Receives: Other: Clinical parameters; Other: Laboratory parameters | |
| Group 2: Obese/overweight women | matched with female patients with lipedema based on age and BMI Receives: Other: Laboratory parameters | |
| Group 3: Healthy women with a BMI<25 | matched with female patients with lipedema of the same age Receives: Other: Laboratory parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
Neutrophil to Lymphocyte Ratio (NLR)
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.
Measured: Baseline
Platelet to Lymphocyte Ratio (PLR)
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.
Measured: Baseline
Monocyte to Lymphocyte Ratio (MLR)
MLR: Calculated as Monocyte/Lymphocyte. High MLR is associated with increased inflammation and impaired immune response.
Measured: Baseline
CRP to Albumin Ratio (CAR)
CAR: Calculated as CRP/Albumin. It is an index reflecting both inflammation and nutritional/protein reserves.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Jun 2026
- Primary completion1 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyza Nur Yucel, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787234
- Sponsor's protocol ID
- 2026-93
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data generated and analyzed during this study will not be publicly shared.
Publications
Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081.
PubMed 36551837Kruppa 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.
PubMed 37575263Duhon 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.
PubMed 35743063Amato 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.
PubMed 40861617Tel 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.
PubMed 41310256
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Inflammatory Indices in Lipedema Compared With BMI-Matched Obesity: The Distinct Clinical Relevance of the C-Reactive Protein-to-Albumin Ratio
- ClinicalTrials.gov ID
- NCT07787234
- Acronym / sponsor ID
- 2026-93
- Conditions
- Lipedema, Inflamation, Inflammation Biomarkers, Obesity & Overweight
- Keywords
- Lipedema, Inflammation , Index, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Female patients with lipedema | – | Other: Clinical parameters, Other: Laboratory parametersFemale patients with lipedema |
| Group 2: Obese/overweight women | – | Other: Laboratory parametersmatched with female patients with lipedema based on age and BMI |
| Group 3: Healthy women with a BMI<25 | – | Other: Laboratory parametersmatched with female patients with lipedema of the same age |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 1. Inclusion Criteria (Patient Group)
- Diagnosis of lipedema
- Female patients aged 18-65 years
- Literacy
- Signing the informed consent form to participate in the study
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical parametersDemographic 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 | Group 1: Female patients with lipedema |
| Laboratory parametersDemographic 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. | Other | Group 1: Female patients with lipedema, Group 2: Obese/overweight women, Group 3: Healthy women with a BMI<25 |
Primary outcome
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.
4 secondary outcomes
Neutrophil to Lymphocyte Ratio (NLR)
Time frame: Baseline
Platelet to Lymphocyte Ratio (PLR)
Time frame: Baseline
Monocyte to Lymphocyte Ratio (MLR)
Time frame: Baseline
CRP to Albumin Ratio (CAR)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 36551837Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390/biomedicines10123081.
- Background: PubMed 37575263Kruppa 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.
- Background: PubMed 35743063Duhon 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.
- Background: PubMed 40861617Amato 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.
- Background: PubMed 41310256Tel 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.
- Individual participant dataSharing planned: No. The individual participant data generated and analyzed during this study will not be publicly shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema and Inflamation, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic Immuno-Inflammation Index (SII) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07787234, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.