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| Name | Class |
|---|---|
| Lipedema Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipedema | Women with all stages of lipedema | ||
| Dercum's disease | Men and women with nodular, mixed and diffuse Dercum's disease | ||
| Control | Sex, age and BMI matched controls. | ||
| Familial Multiple Lipomatosis | Women and men with multiple lipomas and/or angiolipomas | ||
| Madelung's disease | Men and women with different types of Madelung's disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| Transcriptomics of all enrolled subjects from a single timepoint to assess for changes in gene expression in lipedema tissue compared to controls | This is a phenotyping study that collects data as a single time point though studies may occur on different days. | Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time. |
| Metabolomics of all enrolled subjects from a single timepoint to assess for changes in metabolites in lipedema tissue compared to controls | This is a phenotyping study that collects data as a single time point though studies may occur on different days. | Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time. |
| Lipidomics of all enrolled subjects from a single timepoint to assess for changes in lipid particles in lipedema tissue and blood compared to controls | This is a phenotyping study that collects data as a single time point though studies may occur on different days. | Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time. |
| Cytokines of all enrolled subjects from a single timepoint to assess for changes in cytokine arrays in lipedema tissue and blood compared to controls | This is a phenotyping study that collects data as a single time point though studies may occur on different days. | Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time. |
| Myostatin of all enrolled subjects from a single timepoint to assess for levels of myostatin in lipedema tissue and blood compared to controls | This is a phenotyping study that collects data as a single time point though studies may occur on different days. |
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Inclusion Criteria:
Exclusion Criteria:
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Men and women with lipedema and Dercum's disease and controls.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen L Herbst, PhD, MD | Contact | 5206267689 | karenherbst@deptofmed.arizona.edu | |
| Christopher Ussery, MS | Contact | 5206267689 | cussery@email.arizona.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karen L Herbst, PhD, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona College of Medicine (South Campus) | Recruiting | Tucson | Arizona | 85714 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33786515 | Derived | Allen M, Schwartz M, Herbst KL. Interstitial Fluid in Lipedema and Control Skin. Womens Health Rep (New Rochelle). 2020 Oct 14;1(1):480-487. doi: 10.1089/whr.2020.0086. eCollection 2020. |
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The data will be shared with investigators who submit a request.
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| ID | Term |
|---|---|
| D065134 | Lipedema |
| D000274 | Adiposis Dolorosa |
| D000071070 | Familial Multiple Lipomatosis |
| D008069 | Lipomatosis, Multiple Symmetrical |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008068 | Lipomatosis |
| D012871 | Skin Diseases |
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Blood, adipose tissue and DNA
| Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time. |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |