UnknownNot Applicable

Insight Into Subcutaneous Adipose Tissue Disorders

United States500 participantsStarted 2016-06

Plain-language 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.

Who can participate

Age range19 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Transcriptomics of all enrolled subjects from a single timepoint to assess for changes in gene expression in lipedema tissue compared to controls

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

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

Trial details

NCT IDNCT02838277

SponsorUniversity of Arizona

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-06

Contact for this trial

Karen L Herbst, PhD, MD

5206267689 karenherbst@deptofmed.arizona.edu

View on ClinicalTrials.gov More Lipedema trials

Who can participate

Age range19 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.