An observational study in Lipedema, Dercum's Disease and Familial Multiple Lipomatosis, sponsored by University of Arizona. Status unknown at 1 site in United States. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-15.
Sponsored by University of Arizona · Observational
Among 16 studies in Lipedema with a site in United States — 2 open to participants now, 3 under way, none of them phase 3. Lipedema · United States.
Among the 16 studies in Lipedema with a site in United States, this one is one of 2 that started in 2016, is one of 7 observational ones, and was the 2nd registered.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's planned enrollment of 500 is above the median of 90 across 42 observational studies indexed under Lipedema.
Browse Lipedema studies →2 of the 16 studies in Lipedema with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 19 Lipedema studies recruiting now, 3 (16%) set no upper age limit and 16 (84%) stop at 75 or younger; 0 take children under 18; 4 take healthy volunteers.
This study: 19 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2016.
Median enrollment 19 across the 9 interventional studies, 144 across the 7 observational. Of the 12 that completed or were terminated, 3 (25%) have results posted.
5 of 16 have an industry lead sponsor. The 10 most frequent:
University of Arizona is the lead sponsor of 476 studies on the registry; 88 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 30 (59%) have results posted.
University of Arizona has 3 studies filed under Lipedema — fewer than ten, so there is no comparison to draw.
1 of the studies in Lipedema with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05464927University of VirginiaVisualizing Vascular Mechanisms of Lipedema | 2027-01-01 |
Among the 16 studies in Lipedema with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Men and women with lipedema and Dercum's disease and controls.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with all stages of lipedema
Men and women with nodular, mixed and diffuse Dercum's disease
Sex, age and BMI matched controls.
Women and men with multiple lipomas and/or angiolipomas
Men and women with different types of Madelung's disease.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Single time point study with imaging, blood draw, exam and biopsies over multiple days for a total of approximately 8 hours time.
Plan to share: Yes — The data will be shared with investigators who submit a request.
The record gives a start of Jun 2016, a primary completion of Jun 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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