LipedemaINSIGHTNCT02838277
Insight Into Subcutaneous Adipose Tissue Disorders
An observational study of Lipedema and Dercum's Disease, run by University of Arizona at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipedema, Dercum's Disease, Familial Multiple Lipomatosis
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women with lipedema and Dercum's disease and controls.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Arizona College of Medicine (South Campus)
Tucson, Arizona, 85714
Christopher L Ussery, MS, 520-626-7689, treatprogram@deptofmed.arizona.edu
Karen L Herbst, MD, PhD
About this study
Official title: Insight Into Subcutaneous Adipose Tissue Disorders As Part of The TREAT Program (Treatment, Research, Education, Adipose Tissue) at the University of Arizona
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.
Read the 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.
- Keywords
- lymphatic vessels, leaky vessels, hypertrophic adipocyte
- Medical subject headings
- Lipedema, Adiposis Dolorosa, Familial Multiple Lipomatosis, Lipomatosis, Multiple Symmetrical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LipedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Lipedema Foundation
- Responsible party
- Principal investigator, KHerbst, University of Arizona
- Investigators
- Karen L Herbst, PhD, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838277
- Sponsor's protocol ID
- 1602399502A001
- Acronym
- INSIGHT
- Status last verified
- Sep 2017
- First submitted
- 28 Jun 2016
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be shared with investigators who submit a request.
Publications
Straub LG, Funcke JB, Joffin N, Joung C, Al-Ghadban S, Zhao S, Zhu Q, Kruglikov IL, Zhu Y, Langlais PR, Gordillo R, Herbst KL, Scherer PE. Defining lipedema's molecular hallmarks by multi-omics approach for disease prediction in women. Metabolism. 2025 Jul;168:156191. doi: 10.1016/j.metabol.2025.156191. Epub 2025 Mar 15.
PubMed 40097137Allen 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.
PubMed 33786515
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insight Into Subcutaneous Adipose Tissue Disorders As Part of The TREAT Program (Treatment, Research, Education, Adipose Tissue) at the University of Arizona
- ClinicalTrials.gov ID
- NCT02838277
- Acronym / sponsor ID
- INSIGHT / 1602399502A001
- Keywords
- lymphatic vessels, leaky vessels, hypertrophic adipocyte
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Lipedema Foundation
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women with lipedema and Dercum's disease and controls.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Derived from this study: PubMed 40097137Straub LG, Funcke JB, Joffin N, Joung C, Al-Ghadban S, Zhao S, Zhu Q, Kruglikov IL, Zhu Y, Langlais PR, Gordillo R, Herbst KL, Scherer PE. Defining lipedema's molecular hallmarks by multi-omics approach for disease prediction in women. Metabolism. 2025 Jul;168:156191. doi: 10.1016/j.metabol.2025.156191. Epub 2025 Mar 15.
- Derived from this study: PubMed 33786515Allen 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.
- Individual participant dataSharing planned: Yes. The data will be shared with investigators who submit a request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen L Herbst, PhD, MD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lipedema and Dercum's Disease, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen L Herbst, PhD, MD (5206267689, karenherbst@deptofmed.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02838277, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.