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 range

19 Years – 70 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

19 Years – 70 Years

Sex

ALL

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.