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Lipedema clinical trials

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NCT ID: NCT06180850 Recruiting - Lipedema Clinical Trials

Building Lipedema Research Resources

BRR
Start date: February 23, 2024
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT05861583 Recruiting - Lipedema Clinical Trials

Evaluation of Lipoedema Tissue Transcriptome

Start date: January 1, 2023
Phase:
Study type: Observational

Lipoedema is a chronic painful disease with a fat distribution disorder affecting women. It is probably aggravated by hormonal changes. It is also discussed that a genetical predisposition might be a risk factor for developing lipoedema. The mechanisms leading to lipoedema are mostly unknown. The aim of this study is to identify molecular mechanisms and changes of the RNA-Expression pattern causing lipoedema by comparing the transcriptome of subcutaneous tissue of lipoedema patients vs. healthy subcutaneous tissue.

NCT ID: NCT05739279 Recruiting - Sarcopenia Clinical Trials

Sarcopenia and Related Factors in Lipedema

Start date: January 1, 2023
Phase:
Study type: Observational

Lipedema is a common disease of subcutaneous adipose tissue. The most common complaint of patients with swelling in the affected extremity is pain. In addition, patients with lipedema may experience conditions that can greatly affect the health and quality of life of the individual, such as loss of muscle strength and exercise capacity, and deterioration in activity levels of daily living. It is still unknown whether the decrease in muscle strength in patients with lipedema is part of this condition or whether decreased activity levels lead to decreased muscle strength. Sarcopenia is an important health problem characterized by age-related loss of muscle mass and muscle function. The relationship between muscle weakness and sarcopenia in patients with lipedema has not been investigated before. Early recognition of possible sarcopenia and functional limitations in these patients may be important to increase the ability of patients to participate in physical activity as part of their conservative management. There is no study in the literature investigating sarcopenia in patients with a diagnosis of lipedema. The aim of this study is to evaluate patients with a diagnosis of lipedema in terms of sarcopenia. In addition, the relationship between sarcopenia and age, body mass index, exercise frequency, lipedema type, and stage will be investigated in patients diagnosed with lipedema.

NCT ID: NCT05628948 Recruiting - Clinical trials for Cardiovascular Diseases

Vascular Lab Resource (VLR) Biorepository

Start date: November 14, 2019
Phase:
Study type: Observational

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.

NCT ID: NCT05488977 Recruiting - Lipedema Clinical Trials

The Effects of Endurance Training on Lipedema

LipidEx
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Lipedema is a fat disorder causing accumulation of subcutaneous adipose tissue particularly in arms and legs, and predominantly affects women. Lipedema likely contributes to an array of other pathologies, including obesity, inflammatory bowel disease, and neurological disorders. Lipedema tissue is often very painful and can severely impair mobility. The condition can also increase the incidence of depression, anxiety, or eating disorders. There seems to be a general impression that lipedema tissue is difficult to reduce by diet, exercise, or bariatric surgery. However, only a few studies have actually explored the effects of exercise training on lipedema. Despite the lack of knowledge, the existing guidelines for lipidemia treatment promote a healthy lifestyle with individually adjusted weight control measures, including physical activity. In general, exercise is known to have an important effect on adipose tissue. Excess adipose tissue causes macrophage infiltration into the adipose tissue leading to continuous low systemic inflammation. This would suggest that there is a systemic inflammatory response in lipedema patients. Increasing IL-6 levels with exercise can decrease the level of proinflammatory TNFalpha synthesized from adipocytes and therefore lead to an anti-inflammatory effect by increasing IL-10 and IL-1ra levels. IL-6 also stimulates fat oxidation by increasing lipolysis. For these reasons, adding an appropriate exercise program to standard treatment might provide additional benefits for lipedema patients. The investigators aim to determine the therapeutic potential of high-intensity interval training (HIIT) on pain, quality of life, body composition, cardiorespiratory fitness and circulating biomarkers in women with lipedema.

NCT ID: NCT05464927 Recruiting - Lipedema Clinical Trials

Visualizing Vascular Mechanisms of Lipedema

VMP
Start date: September 1, 2021
Phase:
Study type: Observational

This work will address clinical unmet needs for patients with lipedema using advanced magnetic resonance imaging (MRI) methods, in sequence with portable clinical tools, by testing fundamental hypotheses regarding potential screening methods, lymphatic therapy, and vascular dysfunction in patients with lipedema.

NCT ID: NCT05394467 Recruiting - Lipedema Clinical Trials

Adipose Cellular Kinetics of Lipedema

LIPEDEMA
Start date: April 7, 2022
Phase:
Study type: Observational

Lipedema is characterized by an abnormal deposition of adipose tissue, resulting in fluid accumulation, limb enlargement, and pain. Lipedema is often misdiagnosed as simply obesity. A major challenge with diagnosis is the poorly understood biology underlying the disease. Limited studies suggest that the development of lipedema may involve adipocyte hypertrophy, increased commitment of adipose progenitor cells, hypoxia, adipocyte necrosis and macrophage recruitment. There remains an urgent need to investigate novel characteristics of adipose remodeling that may contribute to the pathogenesis of lipedema. The study investigators have reported quantitative measures of in vivo adipose kinetics using an 8-week incorporation of deuterium (administered as 2H2O) into the adipose tissue of women with obesity. The objective of this proposal is to utilize the metabolic 2H-labeling approach to measure, for the first time, in vivo adipocyte formation and triglyceride synthesis in the adipose tissue of participants with lipedema. Imaging approaches will provide a range of measurements to characterize the lipedema depots. The investigators hypothesize that lipedema adipose depots will have higher rates of adipocyte formation and triglyceride synthesis than both non-lipedema depots and those of women with traditional obesity. Lipedema may involve adipose tissue remodeling, characterized by adipocyte hypertrophy and increased commitment of preadipocytes and differentiation of adipocytes (adipogenesis), yielding an abundance of adipocytes with limited capacity to expand and accommodate lipid, resulting in hypoxia, macrophage recruitment, and local/systemic inflammation. Findings from this proposal will contribute to a better understanding of the pathogenesis of lipedema and may provide insight for the future development of therapeutic targets.

NCT ID: NCT05329324 Recruiting - Lipedema Clinical Trials

Is The Pain in Lipedema Patients Neuropathic Pain?

Start date: April 20, 2022
Phase:
Study type: Observational

Lipedema is a chronic progressive disease characterized by abnormal increase of subcutaneous adipose tissue. It is characterized by bilateral enlargement of the lower and/or upper extremities, typically sparing the hands and feet. This disease, which almost always affects women, has rarely been described in men due to hormonal disorders or concomitant diseases such as cirrhosis. Although the results vary, it has been reported that it is seen at a minimum rate of 1:72.000 or 11% of women are affected by this disease. Although it is a common disease, it can often be missed in daily practice. Therefore, it is very important to define the disease clinic well. Lipedema usually presents with swelling in the bilateral extremities. It begins in the post-adolescent period and is progressive. It does not respond to diet and exercise, does not improve with elevation, is spontaneous or painful to touch. Patients describe easy bruising with touch or minor trauma. In early lipedema, pain may be the main complaint in the extremities before the development of skin findings. Because of the absence of a defined clear pain pattern in these patients, diagnosis can be missed and confused with other diseases. In addition, it causes limitations in treatment of the pain. Adipose tissue can cause nociceptive and neuropathic pain because it contains both nociceptive neurons and neural innervation. It isn't known whether lipedema pain is of nociceptive or neuropathic origin. In different studies, the pain pattern is defined in different ways such as hyperalgesia, allodynia, spontaneous pain, blunt, heaviness, pressure, tearing, stabbing, severe and unbearable. In this study, the investigators aim to determine if the pain characteristics of patients with lipedema is neuropathic or not and to define the pain characteristics better in order to ensure earlier recognition and treatment of pain.

NCT ID: NCT05284266 Recruiting - Lipedema Clinical Trials

The National Lipedema Study

Start date: March 11, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05114317 Recruiting - Lipedema Clinical Trials

Characteristics of Pain in Women With Lipoedema

Start date: April 1, 2020
Phase:
Study type: Observational

This observational study will seek to investigate the following questions in women with lipoedema: - pain characteristics, intensity and patterns of pain - the relationships between the characteristics, intensity and patterns of pain and age, ethnicity, location, employment status, levels of anxiety/depression, walking ability, ability to work, relations with other people, impact on sleep and quality of life. - the impact of pain treatments or medications on the intensity of pain. The information will be collected via an online survey and participants will be recruited through social media platforms.