Insight Into Subcutaneous Adipose Tissue Disorders

Status unconfirmed

Conditions studied: Lipedema, Dercum's Disease, Familial Multiple Lipomatosis, Madelung's Disease

In brief

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.

Key facts

Study ID

NCT02838277

Run by

University of Arizona

People needed

500

Starts

2016-06-01

Expected to finish

2018-12-01

Last updated by the study team

2017-09-15

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Ambulatory males and/or females of any race able to understand the consent process.
• 19-70 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.

Where it is running

• University of Arizona College of Medicine (South Campus) — Tucson, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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