Insight Into Subcutaneous Adipose Tissue Disorders

NCT02838277 | Unknown

• 1 other identifier: 1602399502A001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lymphatic vessels; leaky vessels; hypertrophic adipocyte

Outcome Measures

Primary Outcomes (5)

• 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.

  Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.

Study Arms (5)

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.

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women with lipedema and Dercum's disease and controls.

You may qualify if:

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

You may not qualify if:

• HIV infection (because of the associated lipodystrophy and fatty growths \[lipomas\]).
• 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.
• Use of any immunosuppressant or corticosteroid medication.
• 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.
• Use of medications that might cause weight gain (e.g., second generation anti-psychotics).
• Blood donation less than 56 days prior to screening visit.
• Tobacco or marijuana use which may alter inflammation in the body.
• Any antibiotics within the last month.
• Barium enema in the last week which would affect gut bacteria and the MRI.
• Pregnancy due to the risks associated with the fat biopsy in the area of the fetus and because pregnancy will alter hormone levels.

Sponsors & Collaborators

• University of Arizona: lead
• Lipedema Foundation: collaborator

Study Sites (1)

University of Arizona College of Medicine (South Campus)

Tucson, Arizona, 85714, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33786515 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, adipose tissue and DNA

MeSH Terms

Conditions

Lipedema; Adiposis Dolorosa; Familial Multiple Lipomatosis; Lipomatosis, Multiple Symmetrical

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Lipomatosis; Skin Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Karen L Herbst, PhD, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen L Herbst, PhD, MD

CONTACT

5206267689; karenherbst@deptofmed.arizona.edu

Christopher Ussery, MS

CONTACT

5206267689; cussery@email.arizona.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 20, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 15, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)