Clinical Research Directory

Investigation of Systemic Inflammation Markers in Lipedema

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.

The Relationship Between Lipedema and Osteoporosis

The purpose of this study is to evaluate the relationship between lipedema and osteoporosis and to examine factors that may be associated with osteoporosis in individuals with lipedema.

Serum Magnesium Levels in Patients Diagnosed With Lipedema

Female patients diagnosed with lipedema will be divided into two groups based on their Pittsburgh Sleep Quality Index (PSQI) scores: PSQI ≤ 5 and PSQI \> 5. Age, body mass index (BMI), education level, menopausal status (reproductive period, perimenopausal period, postmenopausal period), number of births, duration of illness, occupation, marital status, disease stage, lipedema type, lower extremity functional scale, and the World Health Organization Quality of Life Scale - Short Form (Physical Health, Psychological Health, Social Relationships...)

Aquatic Versus Land-Based Exercise in Women With Lipedema

To evaluate optimal workout environments, a 12-week study assigned women with moderate-to-severe lipedema to three distinct protocols: supervised pool workouts, equivalent land-based training, or basic standard monitoring. Researchers tracked walking endurance alongside tissue composition, fluid levels, pain intensity, and general well-being. The trial posited that structured activity beats routine care alone, with water-based exercise potentially offering superior relief due to buoyancy and hydrostatic fluid compression.

Efficacy of Complex Decongestive Therapy, Exercise and Diet in Women With Lipedema

The purpose of this study is to compare the effectiveness of standard physical therapy methods (Complex Decongestive Therapy, Pneumatic Compression, and Exercise) combined with two different nutritional approaches (personalized anti-inflammatory diet vs. standard healthy nutrition education) in women diagnosed with lower extremity lipedema.

Ultrasonographic Evaluation and Pedobarographic Correlation of Lower Extremity Muscles in Lipedema Patients

This study aims to investigate the relationship between lower extremity muscle/tendon characteristics and walking/balance functions in women with lipedema. Lipedema is a condition characterized by abnormal fat accumulation that can lead to walking difficulties and joint problems. We will use ultrasonography to measure muscle thickness and tendon structures, and a pedobarography system to analyze foot pressure distribution during standing and walking. By comparing 45 patients with 45 healthy volunteers, we aim to identify the musculoskeletal causes of gait disorders in lipedema to help develop better prevention and treatment strategies

Turkish Validation of the Rapprich Lipedema Symptomatic Assessment Questionnaire

Lipedema is a chronic disease characterized by abnormal fat accumulation, primarily in the lower extremities, affecting women. This study aims to evaluate the validity and reliability of the Turkish version of the Rapprich Lipedema Symptomatic Assessment Questionnaire, which was originally developed by Rapprich et al. in 2010. Since a validated Turkish version is currently unavailable, this research will provide a standardized tool for clinicians to assess symptomatic severity in Turkish-speaking lipedema patients.

Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema

Lipedema is a female progressive fat disorder, characterized by a symmetrical increase in subcutaneous adipose tissue in the lower extremities with the exception of the waist. The condition is often misdiagnosed and underdiagnosed. The etiology is poorly understood. Affects about 11% of all women and may lead to pain and immobility. The pathophysiology may be related to sex hormones and inflammatory response. Lipedema fat has been reported not to respond to lifestyle changes or bariatric surgery, both in terms of weight loss and symptom reduction; including pain and quality of life. Clinical research on the effect of dietary interventions on lipedema does not exist, but a pilot study with a ketogenic diet showed a significant reduction in pain regardless of weight loss. The aim of the research project will be to investigate whether a ketogenic diet can be a treatment option for patients with lipedema. Therefore, a randomized controlled trial will be conducted to compare the effects of two diets. 1) energy-restricted ketogenic diet and 3) energy-restricted low-fat non-ketogenic diet for 8 weeks. Pain and quality of life will be mesured at start and immediately after the intervention. The hypothesis is that a ketogenic diet may reduce pain and improve quality of life.

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

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.

Telerehabilitation Versus Supervised Pilates Training in Lipedema Women

1. Pilates Exercise: The Pilates method is a low-intensity form of movement based on body control, which works the body in a complete way, promoting physical and mental health. PET is different when compared to traditional exercises, which, in turn, tend to isolate the working muscles and have specific training approaches using repetitive motions. 2. Telerehabilitation: Telehealth is emerging as a key method for delivering essential healthcare. Primary care research suggests that telehealth is acceptable and has potential to overcome geographical barriers for individuals needing many times rehabilitation by eliminating the need for extensive and costly travel 3. Diet approach: A customized low-carbohydrate high-fat (LCHF) restricted caloric diet in women with lipedema will be used for 12 weeks. The LCHF diet may be a valuable nutritional strategy for lipedema and overweight/obese women, reducing inflammatory status with a beneficial effect on weight, glucose profile the concentration of triglycerides and HDL

Building Lipedema Research Resources

Lipedema is a disease marked by subcutaneous adipose tissue accumulation in the lower extremities of females that is accompanied by somatic pain and edema. Importantly, lipedema is commonly misdiagnosed as obesity, although it's estimated to affect a high 11% of women. Clinical diagnosis of lipedema requires specialized training not widely available at most major medical centers, and there remains a substantial need for objective tools to distinguish lipedema from obesity. There is a critical need to define specific molecular markers of disease in circulation or at the tissue-level. The purpose of this study is to create, manage, and characterize an innovative lipedema biorepository. The goal of the biorepository will be to better understand disease mechanisms of lipedema and to define specific molecular markers of disease in circulation or at the tissue-level. The long-term purpose of our studies are to help with prevention and early management of lipedema.

"Effect of Endermologie-Assisted Physiotherapy on Edema, Pain, and Functional Recovery After Liposuction for Lower-Limb Lipedema"

Lipedema is a chronic condition that mainly affects women and causes abnormal fat accumulation, pain, heaviness, tenderness, swelling, and difficulty with movement, especially in the lower limbs. Liposuction is sometimes used to reduce the abnormal fatty tissue in people with lower-limb lipedema. However, after surgery, patients may still experience swelling, pain, bruising, tissue stiffness, and reduced mobility during recovery. Physiotherapy is an important part of recovery after liposuction for lipedema. It may include compression therapy, manual lymphatic drainage, gentle exercises, walking, skin care, and patient education. These treatments aim to reduce swelling, improve circulation, support tissue healing, and help patients return to daily activities. This study will investigate whether adding Endermologie to a standard physiotherapy program can improve recovery after liposuction for lower-limb lipedema. Endermologie is a non-invasive mechanical massage technique that uses gentle suction and rolling movements to mobilize the skin and soft tissues. It may help support lymphatic drainage, reduce swelling, improve tissue flexibility, and decrease discomfort. Participants in this study will be divided into two groups. One group will receive only standard postoperative physiotherapy. The other group will receive standard postoperative physiotherapy plus Endermologie sessions. The study will compare both groups to see whether Endermologie-assisted physiotherapy provides a better improvement in swelling, pain, tissue stiffness, mobility, and overall functional recovery. The results of this study may help physiotherapists develop more effective rehabilitation protocols for patients recovering from liposuction for lower-limb lipedema.

Evaluation of Physical Activity in Women With Lipedema

This study will be conducted with women diagnosed with lipedema who were referred to the Lymphedema Rehabilitation Unit of the Physiotherapy and Rehabilitation Department at Gazi University Faculty of Health Sciences for physiotherapy recommendations, and with healthy controls with similar characteristics. Demographic and clinical characteristics of individuals meeting the inclusion criteria and voluntarily agreeing to participate in the study will be recorded. Based on patient statements, factors limiting physical activity due to lipedema, and experiences during and after exercise will be recorded. Additionally, individuals' exercise behavior will be assessed using the Stages of Exercise Behavior Change Questionnaire, their physical activity level using the International Physical Activity Questionnaire-Short Form, and their physical activity barriers using the Self-Perceived Barriers for Physical Activity Questionnaire Data obtained from patient statements, scales, and questionnaires will be compared.

Ketogenic Diet in Women With Lipedema

Lipedema is a chronic fat tissue disorder that usually affects the lower limbs, excluding the feet. Clinical symptoms of lipedema include a noticeable disproportion between the upper and lower body, a tendency to easy bruising, and pain in the fatty tissue. It is a common disorder that occurs almost exclusively in women, potentially affecting around 11% of the adult population worldwide. The disease, especially in its advanced stages, has negative psychosocial consequences, leading to social isolation or depression, among other issues. The etiology of the disease is unknown, but genetic, hormonal, and inflammatory factors are likely involved in its pathogenesis. This disorder is characterized by the presence of low-grade inflammation in the fat tissue. The use of reduction diets combined with physical activity or bariatric surgery does not constitute an effective therapeutic approach for lipedema. Recent interventional studies show that an anti-inflammatory ketogenic diet leads to a reduction in leg volume and lipedema symptoms, including pain in the extremities. This study aims to evaluate clinical, metabolic, inflammatory, and vascular characteristics in women with lipedema and to assess potential changes associated with dietary intervention - 7 months of ketogenic diet (low carbohydrate, high fat). Participants undergo clinical, laboratory, and patient-reported outcome assessments to evaluate anthropometric parameters, quality of life, and selected biomarkers. The findings are expected to improve understanding of the biological mechanisms underlying lipedema and to support the development of targeted therapeutic strategies.

Multimodal Ultrasound for Differentiating Lymphedema and Lipedema

The aim of this observational study is to evaluate the diagnostic value of multimodal ultrasonography in differentiating between lymphedema and lipedema. Differentiating these two chronic conditions based solely on clinical examination can be challenging due to overlapping symptoms. This study will utilize various non-invasive ultrasound techniques-including B-mode ultrasound, strain elastography, power Doppler, and quantitative ImageJ analysis-to compare tissue characteristics among patients with lymphedema, patients with lipedema, and healthy controls. The goal is to identify reliable, non-invasive imaging biomarkers that can facilitate early and accurate diagnosis, thereby optimizing patient management.

The Impact of Metabolic Status on Pain and Central Sensitization in Women With Lipedema: A Cross-Sectional Observational Study

The aim of this study is to evaluate the effect of metabolic markers (HOMA-IR, triglyceride/HDL ratio, HbA1c, waist and hip circumference measurements, BMI, etc.) on pain and central sensitization in patients diagnosed with lipedema. The primary objective is to investigate the association between metabolic markers and central sensitization. The secondary objective is to assess the relationship between metabolic markers and pain intensity, pain phenotype, and functional status.

Imaging Lymphatic Function in Normal Subjects and in Persons With Lymphatic Disorders

The purpose of this study is to demonstrate the feasibility of near-infrared fluorescence imaging in subjects with acquired or hereditary lymphedema, in subjects with lipidema and other lymphovascular disorders and in normal health subjects; in order to attempt to correlate imaging phenotype(s) with genotype(s).

Investigation of the Effects of High-Intensity Interval Exercise and Moderate-Intensity Continuous Exercise on Limb Volume, Functional Capacity, and Quality of Life in Patients With Lipedema

This randomized controlled clinical study aims to investigate and compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), when combined with intermittent pneumatic compression (IPC) therapy, on limb volume, functional capacity, pain, fatigue, anxiety, depression, sleep quality, and quality of life in women with lipedema. Lipedema is a chronic, progressive adipose tissue disorder primarily affecting women, characterized by abnormal and symmetrical fat accumulation in the lower extremities that does not improve with weight loss or limb elevation. It is often misdiagnosed as obesity or lymphedema, leading to delayed treatment. Lipedema causes pain, swelling, bruising, mobility limitation, and reduced quality of life. Conservative treatment options include compression therapy, manual lymphatic drainage, and exercise. IPC is a non-invasive treatment used to reduce limb volume and pain while improving function and quality of life. Exercise is also a cornerstone of conservative management, but the optimal exercise intensity for lipedema remains unclear. In this study, 69 female patients aged 18-65 years diagnosed with lipedema according to Halk and Damstra criteria will be randomly assigned into three groups: IPC + Home-based walking program IPC + High-Intensity Interval Training (HIIT) IPC + Moderate-Intensity Continuous Training (MICT) All participants will receive 15 IPC sessions (3 times per week for 5 weeks). The exercise programs (HIIT or MICT) will continue for 10 weeks, supervised by a physiotherapist. The home-based group will be encouraged to walk ≥10,000 steps daily using a pedometer application. Primary outcome: Change in limb volume measured by circumferential measurements and the truncated cone formula. Secondary outcomes: Pain (VAS), functional capacity (6-Minute Walk Test), muscle strength (dynamometry), pressure pain threshold (algometry), physical activity (IPAQ-SF), lower extremity function (LEFS), quality of life (SF-12), sleep quality (PSQI), fatigue (FSS), and anxiety/depression (HADS). Measurements will be taken at baseline (T0), after 15 IPC sessions (T1), and after 30 total sessions or 10 weeks (T2). The investigators hypothesize that both HIIT and MICT combined with IPC will provide superior improvements in physical and psychological outcomes compared to IPC with a home-based walking program alone.

Investigation of Medial Longitudinal Arch and Foot Function in Patients With Lipedema

Lipedema is a chronic adipose tissue disorder that commonly leads to joint laxity, hypermobility, and functional limitations, yet its impact on foot morphology has not been systematically examined. This case-control study aims to investigate whether patients with lipedema exhibit a higher prevalence of generalized joint hypermobility and foot structural abnormalities-specifically pes planus-compared with age- and BMI-matched controls. Using radiographic measurements (Meary angle and calcaneal inclination angle), clinical hypermobility assessment, and validated functional scales, the study seeks to determine the relationship between lipedema, hypermobility, and foot function.

Vascular Lab Resource (VLR) Biorepository

This is a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.

The Effect of Systematic Endurance Training in Treatment of Women With Lipedema

Lipedema is a chronic adipose tissue disorder that primarily affects women. The etiology remains unclear and involves abnormal buildup of fat mainly in the lower limbs. It causes physical and psychological morbidity, often with significant impact of daily life. Effective treatment options are still limited, primary involving conservative measures such as compression therapy. Regular endurance training is known to have positive effects on pain management in other disorders, as well as beneficial effects on obesity management. Thus, LipidEx aims to explore the potential of high-intensity interval training (HIIT) as a novel therapeutic option for women with lipedema. We will now perform a cross-over randomized controlled trial (RCT) exploring the effects of 12 weeks of HIIT compared to a control period of usual care. Primary outcomes include changes in pain, and secondary outcomes include changes in adipose tissue mass and quality of life. Exploratory outcomes include changes in inflammatory markers, metabolites, and lipoprotein subfractions in blood and adipose tissue.

ESWT for Primary Lipedema

This randomized controlled clinical trial aims to evaluate the effectiveness of extracorporeal shockwave therapy (ESWT) when added to standard conservative treatment in women with primary lipedema. Participants will be randomly assigned to receive either standard conservative therapy alone or standard therapy combined with radial ESWT. The study will assess changes in pain intensity (VAS), limb circumference measurements, quality of life (SF-36), and patient satisfaction over an 8-week period. Evaluations will be performed at baseline, at the end of the 4-week treatment phase, and at 4-week follow-up. This trial seeks to provide evidence on whether ESWT offers additional clinical benefit in the management of primary lipedema.

The National Lipedema Study

Lipedema is a chronic condition with a symmetrical accumulation of painful fatty tissue primarily affecting the limbs, sparing hands, feet and trunk. The subcutaneous fatty tissue is disproportionately voluminous and may have a different microstructure and metabolism than the patient's regular fatty tissue. The condition affects almost exclusively women and usually debuts around puberty. Lipedema seems to have a hereditary component, may be affected by hormonal variations and worsens with obesity. Guidelines advocate conservative treatment with compression therapy, weight management, physical activity, life style changes and psychological support;and in some cases surgical treatment such as bariatric surgery and liposuction. Treatment of lipedema is indicated when the condition causes significant pain and inhibits the patient's everyday activities. Well-designed randomized controlled studies on lipedema are lacking. The Ministry of Health and Care Services in Norway has found the scientific documentation for the effects of liposuction to be insufficient and has recommended that surgical treatment of lipedema should be evaluated through a 5-year clinical trial. A national task force, consisting of representatives from all four regional health authorities in Norway has been set up. This task force has now initiated this study. A national multi-center study with homogenous treatment protocols can provide globally sought insight on lipedema and the effect of its treatment regimes, and the findings will be important to adjust future treatment strategies regarding both effect and cost/effectiveness.

Investigation of Central Sensitization and Associated Factors in Patients With Lipedema

This study aims to investigate the presence of central sensitization and its associated parameters in patients with lipedema. Lipedema is a chronic and hereditary condition that primarily affects the lower extremities in women and is often associated with hormonal changes. Symptoms such as pain, swelling, and tenderness are common in lipedema, and these symptoms may be related to central sensitization. Additionally, the ultrasonographic findings and pain sensitivity in lipedema will be compared with those of healthy individuals. This study seeks to contribute to the diagnosis and treatment process of lipedema.