Clinical Trial: Insight Into Subcutaneous Adipose Tissue Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Insight Into Subcutaneous Adipose Tissue Disorders As Part of The TREAT Program (Treatment, Research, Education, Adipose Tissue) at the University of Arizona

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Arizona

Current Primary Outcome:

  • Transcriptomics of all enrolled subjects from a single timepoint to assess for changes in gene expression in lipedema tissue compared to controls [ Time Frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time. ]
    This is a phenotyping study that collects data as a single time point though studies may occur on different days.
  • Metabolomics of all enrolled subjects from a single timepoint to assess for changes in metabolites in lipedema tissue compared to controls [ Time Frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time. ]
    This is a phenotyping study that collects data as a single time point though studies may occur on different days.
  • Lipidomics of all enrolled subjects from a single timepoint to assess for changes in lipid particles in lipedema tissue and blood compared to controls [ Time Frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time. ]
    This is a phenotyping study that collects data as a single time point though studies may occur on different days.
  • Cytokines of all enrolled subjects from a single timepoint to assess for changes in cytokine arrays in lipedema tissue and blood compared to controls [ Time Frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time. ]
    This is a phenotyping study that colle

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University of Arizona

    Dates:
    Date Received: June 28, 2016
    Date Started: June 2016
    Date Completion: December 2018
    Last Updated: July 15, 2016
    Last Verified: July 2016