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Trial record 1 of 1 for:    NCT02838277
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Insight Into Subcutaneous Adipose Tissue Disorders (INSIGHT)

This study is currently recruiting participants.
Verified September 2017 by KHerbst, University of Arizona
Sponsor:
ClinicalTrials.gov Identifier:
NCT02838277
First Posted: July 20, 2016
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Lipedema Foundation
Information provided by (Responsible Party):
KHerbst, University of Arizona
  Purpose
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.

Condition
Lipedema Dercum's Disease Familial Multiple Lipomatosis Madelung's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Insight Into Subcutaneous Adipose Tissue Disorders As Part of The TREAT Program (Treatment, Research, Education, Adipose Tissue) at the University of Arizona

Resource links provided by NLM:


Further study details as provided by KHerbst, University of Arizona:

Primary Outcome Measures:
  • 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 collects data as a single time point though studies may occur on different days.

  • Myostatin of all enrolled subjects from a single timepoint to assess for levels of myostatin 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.


Biospecimen Retention:   Samples With DNA
Blood, adipose tissue and DNA

Estimated Enrollment: 500
Study Start Date: June 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women with lipedema and Dercum's disease and controls.
Criteria

Inclusion Criteria:

  1. Ambulatory males and/or females of any race able to understand the consent process.
  2. 19-70 years of age.
  3. Diagnosis of lipedema, Dercum's disease or familial multiple lipomatosis or other similar fat disorder.
  4. Individuals without a fat disorder (will be matched by age, sex, race and body mass index to individuals in "2").
  5. Weight stable for past three months within a 10 pound range per personal report of the subject.
  6. Overweight or obese (BMI > 26 kg/m2) in order to be able to get enough SAT for the biopsy.
  7. Individuals with BMI < 26 kg/m2 may participate in all aspects of the study protocol except the SAT biopsy.
  8. Thyroid levels in the normal range as confirmed by a TSH level. May have treated hypothyroidism that is stable over 6 months.

Exclusion Criteria:

  1. HIV infection (because of the associated lipodystrophy and fatty growths [lipomas]).
  2. Subjects will be excluded from having a SAT biopsy with any history of scleroderma, keloid formation or other skin condition that would result in substantial scarring after biopsy, a history of recurrent cellulitis, any history of bleeding diathesis that would place the subject at great risk for persistent bleeding after a biopsy/liposuction, any history of major complication after a previous biopsy including requirement of a blood transfusion, hospitalization, failure to heal, or major infection, requiring intravenous antibiotics, or anyone whose skin and tissue would put them at risk for an infection after the biopsy per the assessment of study staff and the principal investigator. These individuals may participate in the remainder of the protocol, just not the SAT biopsy.
  3. Use of any immunosuppressant or corticosteroid medication.
  4. Use of any anti-inflammatory medication such as NSAIDs, aspirin, histamine (H) 1 blocker, H2 blocker, tetracycline or corticosteroids within five days of the study procedure visit.
  5. Use of medications that might cause weight gain (e.g., second generation anti-psychotics).
  6. Blood donation less than 56 days prior to screening visit.
  7. Tobacco or marijuana use which may alter inflammation in the body.
  8. Any antibiotics within the last month.
  9. Barium enema in the last week which would affect gut bacteria and the MRI.
  10. Pregnancy due to the risks associated with the fat biopsy in the area of the fetus and because pregnancy will alter hormone levels.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838277


Contacts
Contact: Karen L Herbst, PhD, MD 5206267689 karenherbst@deptofmed.arizona.edu
Contact: Christopher Ussery, MS 5206267689 cussery@email.arizona.edu

Locations
United States, Arizona
University of Arizona College of Medicine (South Campus) Recruiting
Tucson, Arizona, United States, 85714
Contact: Christopher L Ussery, MS    520-626-7689    treatprogram@deptofmed.arizona.edu   
Principal Investigator: Karen L Herbst, MD, PhD         
Sub-Investigator: Sara Al-Ghadban, PhD         
Sponsors and Collaborators
University of Arizona
Lipedema Foundation
Investigators
Principal Investigator: Karen L Herbst, PhD, MD University of Arizona
  More Information

Responsible Party: KHerbst, Associate Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT02838277     History of Changes
Other Study ID Numbers: 1602399502A001
First Submitted: June 28, 2016
First Posted: July 20, 2016
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be shared with investigators who submit a request.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by KHerbst, University of Arizona:
lymphatic vessels
leaky vessels
hypertrophic adipocyte

Additional relevant MeSH terms:
Lipedema
Lipomatosis
Lipomatosis, Multiple Symmetrical
Familial Multiple Lipomatosis
Adiposis Dolorosa
Connective Tissue Diseases
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Genetic Diseases, Inborn