DRAFT: Clinical Trials that include Lipedema

LF does not fund all of these studies but we are in touch with the research teams. Check clinicaltrials.gov for up-to-date information.

Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema

Samuel Klein, MD

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Washington University School of Medicine

Washington University School of Medicine

NCT03271034

The goals of this project is to conduct a comprehensive characterization of abdominal and femoral fat tissues from women with lipedema and to evaluate the potential effect of a diet-induced weight loss as a therapy.

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HOW TO PARTICIPATE

Lipedema is a disorder characterized by massive, bilateral accumulation of fat below the waist and in the legs. Enlargement of the lower extremities is often accompanied by leg pain and accumulation of fluid. Little is known about the functional changes that lead to fat accumulation and pain in women with lipedema. The goals of this project is to conduct a comprehensive characterization of abdominal and femoral fat tissues from women with lipedema and to evaluate the potential effect of a diet-induced weight loss as a therapy.

Once enrolled in the study, the following tests will be conducted on lipedema subjects: 1) characterization of body composition (fat tissue distribution), insulin sensitivity (response to insulin), adipose tissue biology, and vascular function (how arteries dilate/contract) and immune system function/inflammation. As control, we will have two control populations: BMI-matched women that are metabolically normal obese (MNO) and Metabolically Abnormal Obese (MAO) already analyzed in different studies at Washington University (IRB# 201512086 and 201610005). The MAO and MNO subjects underwent the same testing described above for the lipedema. Therefore, we will use the data generated from IRB# 201512086 and 201610005 as comparison groups in the statistical analysis to understand differences and similarities between lipedema and obesity.

A second aim of the study is to determine the effect of diet-induced weight loss on body composition, insulin sensitivity, adipose tissue biology, and vascular function in the women with lipedema and compare these results with data obtained from BMI-matched women with MAO participating in another study at Washington University (IRB# 201512086). The MAO population will be used as control populations and data generated from the IRB# 201512086 will be used as comparison group for statistical analysis. The results from this second aim of the study will hopefully provide important insights on the efficacy of diet therapy in managing lipedema.

For more information about recruiting efforts for this study contact Dr. Vincenza Cifarelli at 314-273-1386 or by email cifarelli@wustl.edu.


Evaluation of Safety and Efficacy of RZL- 012 for the Treatment of Lipedema or of Nodular Dercum's Disease

Karen Herbst, PhD, MD

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University of Arizona Medical Center Tucson

Raziel Therapeutics

NCT03492840

This trial aims to study RZL-012, a novel compound, in treating lipedema and Dercum's disease by triggering lipolysis at selected sites and reducing fat bringing pain relief and improvement in quality of life.

A vast amount of published information proves that for some people, obesity is not the result of excessive food consumption, poor food choices, and failure to exercise . Problems with mitochondria, leaky lymphatics and other mutations can drive and maintain fat growth that cannot be lost through traditional diet and exercise. Lipedema and Dercum's disease are known as Rare Adipose Disorders. These are painful and progressive disorders that result in abnormal accumulations of fat in the form of lipomas, excess lymphatic fluid, and many other symptoms.

RZL-012 is a novel molecule that enables de-novo generation of thermogenic tissue at favorable anatomical sites. As a result, the extra accumulated fat will be turned into heat and induce lipolysis. This is an open label , Phase 2a clinical trial for the evaluation of safety, efficacy and lipolysis-induction of RZL-012 in women with lipedema involving substantial fat above the knee or women and men with nodular Dercum's disease.

For more information about recruiting efforts for this study contact Chris Ussery at 520-626-7689 or by email cussery@deptofmed.arizona.edu.


Insight into Subcutaneous Adipose Tissue Disorders

Karen Herbst, PhD, MD

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University of Arizona College of Medicine (South Campus) Tucson

University of Arizona

NCT02838277

The INSIGHT study aims to phenotype individuals with subcutaneous adipose tissue (SAT) disorders specifically lipedema and Dercum's disease with an aim to find a cure for the SAT in these disorders that is resistant to diet and exercise.

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HOW TO PARTICIPATE

Lipedema is a syndrome of painful fatty enlargement of the buttocks, hips and thighs primarily in women which cannot be lost by diet, exercise or bariatric surgery. Arms are affected in 80% of women with lipedema to varying degrees. The etiology of lipedema is not known and there are no evidence-based treatments that work for a majority of individuals except for excision of the subcutaneous adipose tissue (SAT) by liposuction which has risks. Millions of women are affected with lipedema yet they are grossly under-diagnosed, have mobility issues and can develop lymphedema. The goal of this project is to better understand the etiology of lipedema SAT, find out how it is different from non-lipedema SAT, to improve our ability to identify the abnormal SAT and determine the response of the tissue to therapeutics by imaging and biomarkers. People with diffuse Dercum's disease (DD) appear to have lipedema plus a tissue inflammation that causes illness and pain. People with SAT disorders that have similarities to lipedema will also be included in this protocol. More research is needed to determine how these fatty disorders are similar and different from each other and from obesity so they can be distinguished clinically and by laboratory testing and imaging. Since these painful fatty disorders are associated with SAT growth, research focused on these disorders may provide unique insight into mechanisms of obesity. This will be accomplished through collecting samples and not specifically testing a before and after treatment.

DFDSFThis will be accomplished through collecting samples and not specifically testing a before and after treatment.


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1) Lymphedema Clinic at Memorial Hermann Hospital in the Texas Medical Center Houston 2) UT Physicians Pediatric Surgery Clinic Houston 3) Wound Care Clinic at CHI St. Luke's The Woodland's Hospital

The University of Texas Health Science Center, Houston

NCT00833599

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Currently, there is no method to assess lymphatic function in persons with acquired (developed following surgery or trauma) lymphedema, hereditary lymphedema or other lympho-vascular disorders. The causes of these disorders, and the means to distinguish between them, is not available from existing diagnostics. A method to monitor lymphatic function could assist in the development of new therapies, the prediction of a patient's susceptibility to develop these disorders, and the evaluation of patient's conditions or responses to therapy and treatment. In this Phase I/II trial, we inject Indocyanine Green (ICG) off-label as a lymph contrast agent and use a custom designed fluorescence imager to conduct near-infrared fluorescence imaging to dynamically follow lymphatic trafficking in subjects. Blood is also collected for DNA analysis. The resulting images are analyzed, and the phenotypes observed in both normal and diseased subjects are used to correlate to mutations of specific genes reported to be associated with lymphatic development.

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